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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160496
• Other study ID #: CEICA;PI13/00108
• Secondary ID: I+CS-HUMS-B80_PI
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: November 30, 2016
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2016
• Source: Instituto Aragones de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité de Investigación Clínica
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 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

Intervention

Behavioral:
• Weight loss interventional study with 20% protein-diet

• Weight loss interventional study with 27% protein-diet

• Weight loss interventional study with 35% protein-diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Aragones de Ciencias de la Salud

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood pressure of diets with different protein composition in overweight and obese women.		After 3 months of intervention.	No
Other	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)	No
Other	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.	No
Primary	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	No
Secondary	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.	No
Secondary	Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.		After 3 months of intervention.	No