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

Obesity Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Diet, Reducing
• Lipids
• Obesity
• Overweight
• Weight Loss

• NCT number: NCT02160496
• Study type: Interventional
• Source: Instituto Aragones de Ciencias de la Salud
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Completion date: November 2014