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
  Purpose

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


Condition Intervention
Obesity
Behavioral: PROOF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Protein Content Determines Weight Gain During High Fat Overfeeding

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Normal Protein (15%) diet
Behavioral: PROOF
dietary overfeeding with high, low or normal protein content
Other Name: Overfeeding with different protein levels.
Experimental: 2
Low Protein (5%) diet
Behavioral: PROOF
dietary overfeeding with high, low or normal protein content
Other Name: Overfeeding with different protein levels.
Experimental: 3
High Protein (25%) diet
Behavioral: PROOF
dietary overfeeding with high, low or normal protein content
Other Name: Overfeeding with different protein levels.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565149

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Steven R Smith, MD Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven R Smith, Pennigton Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00565149     History of Changes
Other Study ID Numbers: PBRC25007, 2005-34323-15741
Study First Received: November 27, 2007
Last Updated: November 25, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014