Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults (COLABOCO)

Obesity is considered the epidemic of the 21st century. Obesity is a multifactorial disease and the most important risk factors are poor diet and sedentary lifestyle. An excessive body weight contributes to increase the risk of suffering from other diseases and mortality rates. Therefore, the prevention and control of excessive body weight as well as its comorbidities are essential. In this sense, the principal strategy to treat obesity is to improve dietary habits and increase physical activity. However, the rate of obesity continues rising. In order to deal with this problem, new strategies to combat obesity are being investigated, such as the investigation of new bioactive compounds with satiating capacity that can be included in healthy dietary patterns to improve adherence to dietary treatments.

Considering this background, the main objective of this research is to assess the effect of daily consumption of protein rich bars accompanied by healthy dietary recommendations on weight loss of overweight/obese adult men and women.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Protein
• Intervention / Treatment: Other: Dietary recommendations including protein enriched bars; Other: Dietary recommendations without protein enriched bars

Detailed Description

This study is designed as a 12-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old.

All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research in the University of Navarra for the screening visit and 4 more times during the intervention (week 1, 4, 8 and 12 of study).

Screening visit: evaluation of the inclusion criteria. Volunteers who meet the inclusion criteria are provided with a feces collection kit, urine collection kit, food frequency questionnaire, visual analogue scale and minnesota physical activity questionnaire. Moreover, they are randomly assigned to one of the two intervention groups:

• Control group: healthy dietary recommendations.
• Experimental group: healthy dietary recommendations + 2 protein rich bars/day

Clinical investigation day 1 (week 1): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in screening visit. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. After that, volunteer is provided with healthy dietary recommendations only or dietary recommendations and protein rich bars, depending on the allocated intervention group. Moreover, volunteer is provided with visual analogue scale to be completed for the Clinical investigation day 2.

Clinical investigation day 2 (week 4): The volunteer attend the Nutrition Intervention Unit. The volunteer is asked to provide the visual analogue scale. Then, gastrointestinal symptoms questionnaire is completed and the adherence to the study is assessed. Then, body weight and blood pressure are measured. Volunteer is provided with fece and urine collection kits, food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale, to be completed for the Clinical investigation day 3. Finally, volunteers allocated in experimental group are provided with protein rich bars.

Clinical investigation day 3 (week 8): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 2. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. Volunteer is provided with fece and urine collection kits, as well as food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale to be completed for the Clinical investigation day 4. Finally, volunteers allocated in experimental group are provided with protein rich bars.

Clinical investigation day 4 (week 12): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 3. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Center for Nutrition Research. University of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Volunteers with BMI between 24.9 and 34.9 kg/m2.
• Physical examination and vital signs normal or clinically irrelevant to the study.
• Volunteers undergoing pharmacological treatment will be included if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function and antidiabetics.
• Subjects must be able to understand and be willing to sign the informed consent, as well as comply with all the procedures and requirements of the study.
• Present a stable weight (+/-3kg) in the last three months before the start of the study.

Exclusion Criteria:

• Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
• Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
• Women who are breastfeeding or pregnant.
• Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
• Subjects with liver disease.
• Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
• Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
• Subjects who present some type of cognitive and/or psychic impairment.
• Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
• Subjects who work night shifts.
• Subjects who follow some type of supplementation that interferes with the study.
• Subjects who are immersed in some treatment for weight loss.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group receiving dietary recommendations including protein enriched bars .; Experimental group will consume two protein enriched bars per day during 12 weeks. First bar will be consumed 45 minutes before lunch and second bar will be consumed 45 minutes before dinner.	Other: Dietary recommendations including protein enriched bars; Volunteers allocated in the experimental group will receive dietary recommendations and 2 protein enriched bars per day to be eaten 45 minutes before lunch and dinner.
Placebo Comparator: Group receiving dietary recommendations without protein enriched bars.; Placebo group will follow just dietary recommendations during 12 weeks.	Other: Dietary recommendations without protein enriched bars; Volunteers allocated in the experimental group will receive dietary recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of weight from baseline to week 4 (bioimpedance)	Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of weight from baseline to week 8 (bioimpedance)	Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of weight from baseline to week 12 (bioimpedance)	Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of weight from week 4 to week 8 (bioimpedance)	Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.	The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 3(after 8 weeks of intervention).
Change of weight from week 4 to week 12 (bioimpedance)	Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.	The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of weight from week 8 to week 12 (bioimpedance)	Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body fat percentage from baseline to week 8 (bioimpedance)	Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat percentage from baseline to week 12 (bioimpedance)	Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat percentage from week 8 to week 12 (bioimpedance)	Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from baseline to week 8 (bioimpedance)	Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat kilograms from baseline to week 12 (bioimpedance)	Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from week 8 to week 12 (bioimpedance)	Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from baseline to week 8 (bioimpedance)	Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body muscle mass from baseline to week 12 (bioimpedance)	Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from week 8 to week 12 (bioimpedance)	Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from baseline to week 8 (bioimpedance)	Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body lean mass from baseline to week 12 (bioimpedance)	Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from week 8 to week 12 (bioimpedance)	Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from baseline to week 8 (bioimpedance)	Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water mass from baseline to week 12 (bioimpedance)	Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from week 8 to week 12 (bioimpedance)	Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from baseline to week 8 (bioimpedance)	Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water percentage from baseline to week 12 (bioimpedance)	Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from week 8 to week 12 (bioimpedance)	Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from baseline to week 8 (bioimpedance)	Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mass from baseline to week 12 (bioimpedance)	Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from week 8 to week 12 (bioimpedance)	Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Height at baseline	Height of participants will be measured by stadiometer and reported in meters.	The Time Frame contains one time point: screening visit.
Change of waist circumference from baseline to week 8	Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of waist circumference from baseline to week 12	Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of waist circumference from week 8 to week 12	Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from baseline to week 8	Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hip circumference from baseline to week 12	Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from week 8 to week 12	Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from baseline to week 8	Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of neck circumference from baseline to week 12	Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from week 8 to week 12	Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from baseline to week 4	Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of systolic blood pressure from baseline to week 8	Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from baseline to week 12	Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from week 4 to week 8	Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from week 8 to week 12	Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from baseline to week 4	Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of diastolic blood pressure from baseline to week 8	Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of diastolic blood pressure from baseline to week 12	Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from week 4 to week 8	Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of diastolic blood pressure from week 8 to week 12	Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of heart rate from baseline to week 4	Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of heart rate from baseline to week 8	Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of heart rate from baseline to week 12	Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of heart rate from week 4 to week 8	Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.	The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of heart rate from week 8 to week 12	Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in percentage from baseline to week 8 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat mass in percentage from baseline to week 12 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in percentage from week 8 to week 12 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in kg from baseline to week 8 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat mass in kg from baseline to week 12 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in kg from week 8 to week 12 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from baseline to week 8 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of lean mass in kg from baseline to week 12 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from week 8 to week 12 (densitometry)	Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from baseline to week 12 (densitometry)	Change of lean mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral concentration from baseline to week 8 (densitometry)	Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral concentration from baseline to week 12 (densitometry)	Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral concentration from week 8 to week 12 (densitometry)	Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density from baseline to week 8 (densitometry)	Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density from baseline to week 12 (densitometry)	Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density from week 8 to week 12 (densitometry)	Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of visceral mass from baseline to week 8 (densitometry)	Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of visceral mass from baseline to week 12 (densitometry)	Change of visceral mass density of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of visceral mass from week 8 to week 12 (densitometry)	Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of L1-L4 bone mineral density from baseline to week 8 (densitometry)	Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of L1-L4 bone mineral density from baseline to week 12 (densitometry)	Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of L1-L4 bone mineral density from week 8 to week 12 (densitometry)	Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total bone mineral density of femur from baseline to week 8 (densitometry)	Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of total bone mineral density of femur from baseline to week 12 (densitometry)	Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total bone mineral density of femur from week 8 to week 12 (densitometry)	Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of femur neck from baseline to week 8 (densitometry)	Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density of femur neck from baseline to week 12 (densitometry)	Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of femur neck from week 8 to week 12 (densitometry)	Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of radius from baseline to week 8 (densitometry)	Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density of radius from baseline to week 12 (densitometry)	Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of radius from week 8 to week 12 (densitometry)	Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of glucose concentration from baseline to week 8	Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of glucose concentration from baseline to week 12	Change of glucose levels of participants in fasting condition will be analyzed by absorptiometry and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of glucose concentration from week 8 to week 12	Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total cholesterol concentration from baseline to week 8	Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of total cholesterol concentration from baseline to week 12	Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total cholesterol concentration from week 8 to week 12	Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of HDL cholesterol concentration from baseline to week 8	Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of HDL cholesterol concentration from baseline to week 12	Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of HDL cholesterol concentration from week 8 to week 12	Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of LDL cholesterol concentration from baseline to week 8	Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of LDL cholesterol concentration from baseline to week 12	Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of LDL cholesterol concentration from week 8 to week 12	Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of triglyceride concentration from baseline to week 8	Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of triglyceride concentration from baseline to week 12	Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of triglyceride concentration from week 8 to week 12	Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of alanine aminotransferase concentration from baseline to week 8	Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of alanine aminotransferase concentration from baseline to week 12	Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.	The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of alanine aminotransferase concentration from week 8 to week 12	Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.	The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of aspartate aminotransferase concentration from baseline to week 8	Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of aspartate aminotransferase concentration from baseline to week 12	Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of aspartate aminotransferase concentration from week 8 to week 12	Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of homocysteine concentration from baseline to week 8	Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of homocysteine concentration from baseline to week 12	Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of homocysteine concentration from week 8 to week 12	Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of C-reactive protein concentration from baseline to week 8	Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of C-reactive protein concentration from baseline to week 12	Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of C-reactive protein concentration from week 8 to week 12	Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hemogram concentration from baseline to week 8	Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hemogram concentration from baseline to week 12	Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hemogram concentration from week 8 to week 12	Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of albumin concentration from baseline to week 8	Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of albumin concentration from baseline to week 12	Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of albumin concentration from week 8 to week 12	Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of creatinine concentration from baseline to week 8	Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 8 weeks of intervention).
Change of creatinine concentration from baseline to week 12	Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of creatinine concentration from week 8 to week 12	Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of physical activity level from baseline to week 8	Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of physical activity level from baseline to week 12	Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of physical activity level from week 8 to week 12	Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of dietary intake from baseline to week 8	Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of dietary intake from baseline to week 12	Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of dietary intake from week 8 to week 12	Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hunger from baseline to week 4	The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of hunger from baseline to week 8	The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hunger from baseline to week 12	The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hunger from week 4 to week 8	The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hunger from week 8 to week 12	The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of fullness from baseline to week 4	The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of fullness from baseline to week 8	The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of fullness from baseline to week 12	The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of fullness from week 4 to week 8	The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of fullness from week 8 to week 12	The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of satisfaction sensation from baseline to week 4	The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of satisfaction sensation from baseline to week 8	The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of satisfaction sensation from baseline to week 12	The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of satisfaction sensation from week 4 to week 8	The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of satisfaction sensation from week 8 to week 12	The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of want to eat something else sensation from baseline to week 4	The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of want to eat something else sensation from baseline to week 8	The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of want to eat something else sensation from baseline to week 12	The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of want to eat something else sensation from week 4 to week 8	The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of want to eat something else sensation from week 8 to week 12	The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of thirst sensation from baseline to week 4	The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of thirst sensation from baseline to week 8	The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of thirst sensation from baseline to week 12	The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of thirst sensation from week 4 to week 8	The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.	The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of thirst sensation from week 8 to week 12	The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 4	The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 8	The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 12	The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.	The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of gastrointestinal symptoms from week 4 to week 8	The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.	The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of gastrointestinal symptoms from week 8 to week 12	The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.	The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Bar acceptance at week 12	Bar acceptance will be analyzed by acceptance questionnaire.	The Time Frame contains Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bar consumption record from baseline to week 4	Change of bar consumption will be analyzed by bar consumption record.	The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of bar consumption record from baseline to week 8	Change of bar consumption will be analyzed by bar consumption record.	The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bar consumption record from baseline to week 12	Change of bar consumption will be analyzed by bar consumption record.	The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bar consumption record from week 4 to week 8	Change of bar consumption will be analyzed by bar consumption record.	The Time Frame contains Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bar consumption record from week 8 to week 12	Change of bar consumption will be analyzed by bar consumption record.	The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change in urine and feces hydroxyproline concentration from baseline to week 8	Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8	The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change in urine and feces hydroxyproline concentration from baseline to week 12	Change of hydroxyproline concentration will be analyzed by colorimetry technique	The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change in urine and feces hydroxyproline concentration from week 8 to week 12	Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8	The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Principal Investigator: María Ángeles Zulet, Professor, Center for Nutrition Research, University of Navarra.; Study Chair: Carlos J González Navarro, PhD, Center for Nutrition Research, University of Navarra.; Study Chair: Fermín I Milagro Yoldi, PhD, Center for Nutrition Research, University of Navarra.; Study Chair: Idoia Ibero Baraibar, PhD, Center for Nutrition Research, University of Navarra.; Study Chair: Itziar Abete Goñi, PhD, Center for Nutrition Research, University of Navarra.; Study Chair: Miguel López Yoldi, PhD, Center for Nutrition Research, University of Navarra.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight loss; Satiety; Protein
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: COLABOCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No