A Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean Red Meat - in Body Weight and Lipid Profile in Overweight and Obese Women

A Randomized Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean Red Meat - in Body Weight and Lipid Profile in Overweight and Obese Women

The objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. A dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss; Diet, Reducing; Lipids
• Intervention / Treatment: Behavioral: Weight loss interventional study with 20% protein-diet; Behavioral: Weight loss interventional study with 27% protein-diet; Behavioral: Weight loss interventional study with 35% protein-diet

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age: 18-80 years old.
• Body mass index between 27.5 - 40.
• Steady weight in last 3 months (±3 kg).
• Informed consent provided.

Exclusion Criteria:

• Presence of uncontrolled endocrinological pathology (including hypothyroidism).
• Type 2 diabetes mellitus with bad metabolic control (HbA1c > 8%).
• Lipid-lowering drugs in the last 3 months.
• Intake of functional foods with plant sterols in the past 6 weeks.
• Vitamin supplements intake.
• Hormone replacement therapy.
• Consumption of Orlistat in the last 2 months
• High intake of alcohol (> 30 gr./day).
• Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.
• Pregnancy or intention of pregnancy during the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 20% protein hypocaloric diet; Participants were advised with a hypocaloric diet with the following composition: 20% protein, 30% fat and 50% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects.	Behavioral: Weight loss interventional study with 20% protein-diet
Active Comparator: 27% protein hypocaloric diet; Participants were advised with a hypocaloric diet with the following composition: 27% protein, 30% fat and 43% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects.	Behavioral: Weight loss interventional study with 27% protein-diet
Active Comparator: 35% protein hypocaloric diet; Participants were advised with a hypocaloric diet with the following composition: 35% protein, 30% fat and 35% carbohydrates. A wide variety of healthy foods typically coming from a mediterranean diet and specific exercise recommendations are provided to the subjects.	Behavioral: Weight loss interventional study with 35% protein-diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight and lipid profile of diets with different protein composition in overweight and obese women..	The main outcome is to study the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from lean red meat, on body weight and lipid profile in overweight and obese women.	After 3 months of intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in body composition (by including waist circumference, fat mass and muscle mass) of diets with different protein composition in overweight and obese women.	After 3 months of intervention.
Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.	After 3 months of intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure of diets with different protein composition in overweight and obese women.		After 3 months of intervention.
Change in body weight of diets with different protein composition in overweight and obese women..	In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.	After 3 months of study completion (at 6-months after beginning the study)
Change in adipokines concentration of diets with different protein composition in overweight and obese women.	In 3-months visits serum plasma, adipokines concentration will be determined.	After 3 months of study completion.

Collaborators and Investigators

• Sponsor: Instituto Aragones de Ciencias de la Salud
• Investigators: Principal Investigator: Fernando Civeira, MD, PhD, Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain); Principal Investigator: Rocio Mateo-Gallego, MSc, Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)

Publications and helpful links

General Publications

• Mateo-Gallego R, Lamiquiz-Moneo I, Perez-Calahorra S, Marco-Benedi V, Bea AM, Baila-Rueda L, Laclaustra M, Penalvo JL, Civeira F, Cenarro A. Different protein composition of low-calorie diet differently impacts adipokine profile irrespective of weight loss in overweight and obese women. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):133-142. doi: 10.1016/j.numecd.2017.10.024. Epub 2017 Nov 4.
• Mateo-Gallego R, Marco-Benedi V, Perez-Calahorra S, Bea AM, Baila-Rueda L, Lamiquiz-Moneo I, de Castro-Oros I, Cenarro A, Civeira F. Energy-restricted, high-protein diets more effectively impact cardiometabolic profile in overweight and obese women than lower-protein diets. Clin Nutr. 2017 Apr;36(2):371-379. doi: 10.1016/j.clnu.2016.01.018. Epub 2016 Jan 29.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 8, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight Loss; Lipids; Diet, Reducing
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: CEICA;PI13/00108; I+CS-HUMS-B80_PI13/00108 (Other Identifier: I+CS-HUMS-B80)