PROOF: PROtein OverFeeding Effect on Body Weight

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT00565149
Collaborator
United States Department of Agriculture (USDA) (U.S. Fed)
60
1
3
132
0.5

Study Details

Study Description

Brief Summary

This study is designed to determine the effects of dietary protein content on overfeeding.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PROOF
N/A

Detailed Description

When body weight increases, the expenditure of energy increases as a mechanism to dissipate the excess calories. The role of diet composition in over-feeding/energy dissipation in humans is unknown. We propose that:

  1. High and low protein diet will result in less weight gain as compared to a moderate protein diet during a 56d high fat overfeeding.

  2. Increase in energy expenditure and spontaneous physical activity, adjusted for lean and fat mass will be greater in the high and low protein diets as compared to a moderate protein diet.

  3. the average size of the fat cells and the pattern of genes expressed in the adipose tissue, skeletal muscle, and peripheral blood mononuclear cells will "predict" which group of subjects will gain the most weight (and fat mass) independent of the level of the protein in the diet.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dietary Protein Content Determines Weight Gain During High Fat Overfeeding
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Normal Protein (15%) diet

Behavioral: PROOF
dietary overfeeding with high, low or normal protein content
Other Names:
  • Overfeeding with different protein levels.
  • Experimental: 2

    Low Protein (5%) diet

    Behavioral: PROOF
    dietary overfeeding with high, low or normal protein content
    Other Names:
  • Overfeeding with different protein levels.
  • Experimental: 3

    High Protein (25%) diet

    Behavioral: PROOF
    dietary overfeeding with high, low or normal protein content
    Other Names:
  • Overfeeding with different protein levels.
  • Outcome Measures

    Primary Outcome Measures

    1. To determine the effect of overfeeding 40% above energy balance with a low (5%) or high (25%) vs. normal (15%) protein diet on body weight and body composition as well as energy expenditure and its components. [baseline and after 8 weeks of overfeeding]

    Secondary Outcome Measures

    1. To relate the baseline characteristics of the subjects [fat cell size, pattern of gene expression, body composition, family history of obesity, etc] to the degree of weight / fat gain during overfeeding. [baseline and after 8 Weeks of over feeding]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Have a BMI of 19-30kg/m2 A cutpoint of 26kg/m2 will be used to allocate treatment across the three diets. See the statistics section for more detail.

    • Are willing to eat all of the study foods even when full

    • Are willing to eat only foods provided by Pennington and all of the foods provided

    • Are willing to live at Pennington for 10-12 weeks possibly without leaving the metabolic unit the entire time

    • Are willing to avoid exercise while in the inpatient phase of the study

    • Age 18 - 35

    Exclusion Criteria:

    Participants are ineligible to participate in the study if they…

    • Smoke

    • Have Diabetes

    • Have claustrophobia

    • Have a Fasting Blood Sugar >110

    • Have a history of cardiovascular disease

    • Have an average screening blood pressure >140/90

    • Have a history of a major psychiatric, addictive or eating disorder or any psychosocial or scheduling factors that could impede study outcomes

    • Post obese (self-reported BMI) must never have had a BMI greater than 32

    • Exercise more than 2 hours per week

    • Unable to complete VO2 max test.

    • Weight gain or loss of > 3kg in the last 6 months

    • Have significant renal, hepatic, endocrine, pulmonary or hematological disease, or a history of gout

    • Have had previous GI surgery, Obstructive disease of the GI tract, Hypermotility disorder or a history of problems of impairment of the gag reflex.

    • Corticosteroid use in the last 2 Months

    • You are pregnant or breastfeeding

    • Have Irregular menstrual cycles

    • Use Depo-Provera, hormone implant or estrogen replacement therapy

    • Have an allergy to PABA (a component of a B-vitamin often found in sunscreen)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center
    • United States Department of Agriculture (USDA)

    Investigators

    • Principal Investigator: Steven R Smith, MD, Pennington Biomedical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leanne Redman, Professor, Adjunct, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT00565149
    Other Study ID Numbers:
    • PBRC 25007
    • 2005-34323-15741
    First Posted:
    Nov 29, 2007
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Aug 1, 2021

    Study Results

    No Results Posted as of Aug 25, 2021