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PROOF: PROtein OverFeeding Effect on Body Weight

This study has been completed.
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00565149
First received: November 27, 2007
Last updated: November 25, 2009
Last verified: November 2009
History of Changes

November 27, 2007
November 25, 2009
March 2005
March 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: baseline and after 8 weeks of overfeeding ] [ Designated as safety issue: No ]
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. [ Time Frame: 8 weeks of overfeeding ]
Complete list of historical versions of study NCT00565149 on ClinicalTrials.gov Archive Site
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. [ Time Frame: baseline and after 8 Weeks of over feeding ] [ Designated as safety issue: No ]
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. [ Time Frame: 8 Weeks of over feeding ]
Not Provided
Not Provided
 
PROOF: PROtein OverFeeding Effect on Body Weight
Dietary Protein Content Determines Weight Gain During High Fat Overfeeding

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

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
Behavioral: PROOF
dietary overfeeding with high, low or normal protein content
Other Name: Overfeeding with different protein levels.
  • Experimental: 1
    Normal Protein (15%) diet
    Intervention: Behavioral: PROOF
  • Experimental: 2
    Low Protein (5%) diet
    Intervention: Behavioral: PROOF
  • Experimental: 3
    High Protein (25%) diet
    Intervention: Behavioral: PROOF
Bray GA, Smith SR, de Jonge L, Xie H, Rood J, Martin CK, Most M, Brock C, Mancuso S, Redman LM. Effect of dietary protein content on weight gain, energy expenditure, and body composition during overeating: a randomized controlled trial. JAMA. 2012 Jan 4;307(1):47-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2008
March 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00565149
PBRC25007, 2005-34323-15741
Yes
Steven R Smith, Pennigton Biomedical Research Center
Pennington Biomedical Research Center
USDA Beltsville Human Nutrition Research Center
Principal Investigator: Steven R Smith, MD Pennington Biomedical Research Center
Pennington Biomedical Research Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP