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

Sponsor

Instituto Aragones de Ciencias de la Salud (Other)

Overall Status

Completed

CT.gov ID

NCT02160496

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Obesity Overweight Diet, Reducing Lipids	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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. [After 3 months of intervention]
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.

Secondary Outcome Measures

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

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.. [After 3 months of study completion (at 6-months after beginning the study)]
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.
Change in adipokines concentration of diets with different protein composition in overweight and obese women. [After 3 months of study completion.]
In 3-months visits serum plasma, adipokines concentration will be determined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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)