Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Overweight
Diet, Reducing
Lipids
Keywords: Weight Loss
Obesity
Overweight
Diet, Reducing
Lipids
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
First posted: 2014-06-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in body weight and lipid profile of diets with different protein composition in overweight and obese women..
timeFrame: After 3 months of intervention
Secondary outcomes:
measure: Change in body composition (by including waist circumference, fat mass and muscle mass) of diets with different protein composition in overweight and obese women.
timeFrame: After 3 months of intervention.
measure: Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.
timeFrame: After 3 months of intervention.
Other outcomes:
measure: Change in blood pressure of diets with different protein composition in overweight and obese women.
timeFrame: After 3 months of intervention.
measure: Change in body weight of diets with different protein composition in overweight and obese women..
timeFrame: After 3 months of study completion (at 6-months after beginning the study)
measure: Change in adipokines concentration of diets with different protein composition in overweight and obese women.
timeFrame: After 3 months of study completion.
Locations:
Study officials:
affiliation: Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
name: Fernando Civeira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
name: Rocio Mateo-Gallego, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.