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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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ClinicalTrials.gov Identifier: NCT02160496
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud

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.

Condition or disease Intervention/treatment Phase
Weight Loss Obesity Overweight Diet, Reducing Lipids Behavioral: Weight loss interventional study with 20% protein-diet Behavioral: Weight loss interventional study with 27% protein-diet Behavioral: Weight loss interventional study with 35% protein-diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Weight loss interventional study with 20% protein-diet
Active Comparator: 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.
Behavioral: Weight loss interventional study with 27% protein-diet
Active Comparator: 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.
Behavioral: Weight loss interventional study with 35% protein-diet



Primary Outcome Measures :
  1. Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. [ Time Frame: After 3 months of intervention ]
    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 :
  1. 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. ]
  2. Change in carbohydrates metabolism of diets with different protein composition in overweight and obese women. [ Time Frame: After 3 months of intervention. ]

Other Outcome Measures:
  1. Change in blood pressure of diets with different protein composition in overweight and obese women. [ Time Frame: After 3 months of intervention. ]
  2. Change in body weight of diets with different protein composition in overweight and obese women.. [ Time Frame: 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.

  3. Change in adipokines concentration of diets with different protein composition in overweight and obese women. [ Time Frame: After 3 months of study completion. ]
    In 3-months visits serum plasma, adipokines concentration will be determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160496


Sponsors and Collaborators
Instituto Aragones de Ciencias de la Salud
Investigators
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Principal Investigator: Fernando Civeira, MD, PhD Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Principal Investigator: Rocio Mateo-Gallego, MSc Unidad de Lípidos/Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando Civeira, Professor, Instituto Aragones de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT02160496    
Other Study ID Numbers: CEICA;PI13/00108
I+CS-HUMS-B80_PI13/00108 ( Other Identifier: I+CS-HUMS-B80 )
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Keywords provided by Fernando Civeira, Instituto Aragones de Ciencias de la Salud:
Weight Loss
Obesity
Overweight
Diet, Reducing
Lipids
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Loss
Body Weight Changes