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NCT Number: NCT02160496

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

Primary outcomes

  1. Change in body weight and lipid profile of diets with different protein composition in overweight and obese women..

    Time frame: 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 outcomes

  1. Change in body composition (by including waist circumference, fat mass and muscle mass) of diets with different protein composition in overweight and obese women.

    Time frame: After 3 months of intervention.

  2. Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.

    Time frame: After 3 months of intervention.

Other outcomes

  1. Change in blood pressure of diets with different protein composition in overweight and obese women.

    Time frame: After 3 months of intervention.

  2. Change in body weight of diets with different protein composition in overweight and obese women..

    Time frame: 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.

  3. Change in adipokines concentration of diets with different protein composition in overweight and obese women.

    Time frame: After 3 months of study completion.

    In 3-months visits serum plasma, adipokines concentration will be determined.

Sponsors and collaborators

Lead sponsor

Instituto Aragones de Ciencias de la Salud

Other Gov

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2014
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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