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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

Primary Purpose

Weight Loss, Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weight loss interventional study with 20% protein-diet
Weight loss interventional study with 27% protein-diet
Weight loss interventional study with 35% protein-diet
Sponsored by
Instituto Aragones de Ciencias de la Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Weight Loss, Obesity, Overweight, Diet, Reducing, Lipids

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    20% protein hypocaloric diet

    27% protein hypocaloric diet

    35% protein hypocaloric diet

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 5, 2014
    Last Updated
    November 30, 2016
    Sponsor
    Instituto Aragones de Ciencias de la Salud
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02160496
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Aragones de Ciencias de la Salud

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss, Obesity, Overweight, Diet, Reducing, Lipids
    Keywords
    Weight Loss, Obesity, Overweight, Diet, Reducing, Lipids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    20% protein hypocaloric diet
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    27% protein hypocaloric diet
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    35% protein hypocaloric diet
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Weight loss interventional study with 20% protein-diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    Weight loss interventional study with 27% protein-diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    Weight loss interventional study with 35% protein-diet
    Primary Outcome Measure Information:
    Title
    Change in body weight and lipid profile of diets with different protein composition in overweight and obese women..
    Description
    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.
    Time Frame
    After 3 months of intervention
    Secondary Outcome Measure Information:
    Title
    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.
    Title
    Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women.
    Time Frame
    After 3 months of intervention.
    Other Pre-specified Outcome Measures:
    Title
    Change in blood pressure of diets with different protein composition in overweight and obese women.
    Time Frame
    After 3 months of intervention.
    Title
    Change in body weight of diets with different protein composition in overweight and obese women..
    Description
    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.
    Time Frame
    After 3 months of study completion (at 6-months after beginning the study)
    Title
    Change in adipokines concentration of diets with different protein composition in overweight and obese women.
    Description
    In 3-months visits serum plasma, adipokines concentration will be determined.
    Time Frame
    After 3 months of study completion.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando Civeira, MD, PhD
    Organizational Affiliation
    Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Rocio Mateo-Gallego, MSc
    Organizational Affiliation
    Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29329923
    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.
    Results Reference
    derived
    PubMed Identifier
    26875447
    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.
    Results Reference
    derived

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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

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