PROOF: PROtein OverFeeding Effect on Body Weight - Full Text View

Sponsors and Collaborators:	Pennington Biomedical Research Center United States Department of Agriculture
Information provided by:	Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00565149

Purpose

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

Condition	Intervention
Obesity	Behavioral: PROOF

MedlinePlus related topics: Dietary Proteins Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	Dietary Protein Content Determines Weight Gain During High Fat Overfeeding

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
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Normal Protein (15%) diet	Behavioral: PROOF dietary overfeeding with high, low or normal protein content
2: Experimental Low Protein (5%) diet	Behavioral: PROOF dietary overfeeding with high, low or normal protein content
3: Experimental High Protein (25%) diet	Behavioral: PROOF dietary overfeeding with high, low or normal protein content

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:

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

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

Contacts

Contact: Susan K Mancuso, BSN

225-763-2618

mancussk@pbrc.edu

Locations

United States, Louisiana
Pennington Biomedical Research Center	Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Steven Smith, MD

Sponsors and Collaborators

Pennington Biomedical Research Center

United States Department of Agriculture

Investigators

Principal Investigator:

Steven R Smith, MD

Pennington Biomedical Research Center

More Information

Responsible Party:	Pennigton Biomedical Research Center ( Steven R Smith )
Study ID Numbers:	PBRC25007, 2005-34323-15741
Study First Received:	November 27, 2007
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00565149
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Weight Gain

ClinicalTrials.gov processed this record on January 15, 2009