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

NCT ID: NCT02160496

Last Updated: 2016-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Weight loss interventional study with 20% protein-diet

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Weight loss interventional study with 27% protein-diet

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Weight loss interventional study with 35% protein-diet

Intervention Type: BEHAVIORAL

Interventions

Weight loss interventional study with 20% protein-diet

Intervention Type: BEHAVIORAL

Weight loss interventional study with 27% protein-diet

Intervention Type: BEHAVIORAL

Weight loss interventional study with 35% protein-diet

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Aragones de Ciencias de la Salud

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fernando Civeira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Civeira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)

Rocio Mateo-Gallego, MSc

Role: PRINCIPAL_INVESTIGATOR

Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)

References

Mateo-Gallego R, Lamiquiz-Moneo I, Perez-Calahorra S, Marco-Benedi V, Bea AM, Baila-Rueda L, Laclaustra M, Penalvo JL, Civeira F, Cenarro A. Different protein composition of low-calorie diet differently impacts adipokine profile irrespective of weight loss in overweight and obese women. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):133-142. doi: 10.1016/j.numecd.2017.10.024. Epub 2017 Nov 4.

Reference Type: DERIVED

PMID: 29329923 (View on PubMed)

Mateo-Gallego R, Marco-Benedi V, Perez-Calahorra S, Bea AM, Baila-Rueda L, Lamiquiz-Moneo I, de Castro-Oros I, Cenarro A, Civeira F. Energy-restricted, high-protein diets more effectively impact cardiometabolic profile in overweight and obese women than lower-protein diets. Clin Nutr. 2017 Apr;36(2):371-379. doi: 10.1016/j.clnu.2016.01.018. Epub 2016 Jan 29.

Reference Type: DERIVED

PMID: 26875447 (View on PubMed)

Other Identifiers

I+CS-HUMS-B80_PI13/00108

Identifier Type: OTHER

Identifier Source: secondary_id

CEICA;PI13/00108

Identifier Type: -

Identifier Source: org_study_id