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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02160496
Enrollment
90
Registered
2014-06-10
Start date
2014-04-30
Completion date
2014-11-30
Last updated
2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALWeight loss interventional study with 20% protein-diet
BEHAVIORALWeight loss interventional study with 27% protein-diet
BEHAVIORALWeight loss interventional study with 35% protein-diet

Sponsors

Instituto Aragones de Ciencias de la Salud
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in body weight and lipid profile of diets with different protein composition in overweight and obese women..After 3 months of interventionThe 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

MeasureTime 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

MeasureTime frameDescription
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026