Weight Regain After Consumption of Food Supplement and Interventional Diet Program (fat-binder)

Clinical Trial to Evaluate the Usefulness of the Regular Consumption of a Food Supplement(FAT-BINDER DAMM) on Weight Regain After an Interventional Diet Program on Overweight/Obese People

Effect of the dietary supplement (FAT-BINDER DAMM) on weight regain after 9 months of control weight program

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss; Body Weight Changes; Weight Change, Body
• Intervention / Treatment: Dietary supplement: Fat-binder damm; Dietary supplement: Placebo

Detailed Description

• 60 participants will consume experimental product every day 3 sticks of the dietary supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the 12 first weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period). When PPP period is over, volunteers will continue consuming the product for 9 months more (Post-PPP period).
• 60 participants will consume everyday 3 placebo sticks (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the first 12 weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period ). When PPP period is over, volunteers will continue consuming the product for 9 months more.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Institute for Health Research IdiPAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women ranging from 18 to 65 years old.
• BMI ≥27 and <40 kg/m2. Overweight type II, obesity type I and II
• Social or familiar environment that prevents from accomplishing the dietary treatment.
• Willingness to follow a balanced hypocaloric diet in order to lose weight and perform regular physical adapted activity.
• Adequate cultural level and understanding of the clinical trial.
• Signed informed consent.

Exclusion Criteria:

• Individuals diagnosed with Diabetes Mellitus type I.
• Individuals diagnosed with Diabetes Mellitus type II on pharmacological treatment.
• Individuals with dyslipidemia on pharmacological treatment.
• Individuals with hypertension on pharmacological treatment uncontrolled.
• Individuals allergic to yeast.
• Individuals with chronic diseases (hepatic, kidney…).
• Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
• Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs).
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental product : FAT-BINDER DAMM; 3 sticks of the dietary supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.	Dietary supplement: Fat-binder damm; 3 sticks every day during 12 months
Placebo Comparator: Control product : PLACEBO; 3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.	Dietary supplement: Placebo; 3 sticks every day during 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Regain	Change from baseline in kilograms	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (weight/height^2)	Change from baseline in kg/m^2	12 months
Fat mass percentage	Change from baseline in percentage	12 months
Body water percentage	Change from baseline in percentage	12 months
Lean mass percentage	Change from baseline in percentage	12 months
Triglycerides	Change from baseline	12 months
Low density lipoprotein cholesterol	Change from baseline	12 months
High density lipoprotein cholesterol	Change from baseline	12 months
Fiber	Change from baseline	12 months
Satiety evaluation	Visual Analog Scale to evaluate motivation-satiety when eating	[Just before eating the product; Just after eating; After 60 minutes; After 90 minutes] Fasting for at least 4 hours. Must do it with a snack accompanied and 500 ml water.
24 hours Dietary Recall	24 hours Food habits of overweight and obesity people	12 months
Sensory perception	Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.	Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.
International Physical Activity Questionnaire	People physical activity habits	12 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Investigators: Principal Investigator: Carmen Gómez Candela, PhD, MS, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight Loss; Beta-glucans; Body weight maintenance; Weight Change, Body; Saccharomyces Cerevisiae
• Additional Relevant MeSH Terms: Weight Loss; Overweight; Body Weight; Body Weight Changes
• Other Study ID Numbers: 4801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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