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Clinical Trials/NCT00565149
NCT00565149
Completed
Not Applicable

Dietary Protein Content Determines Weight Gain During High Fat Overfeeding

Pennington Biomedical Research Center1 site in 1 country60 target enrollmentMarch 2005
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Pennington Biomedical Research Center
Enrollment
60
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
March 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leanne Redman

Professor, Adjunct

Pennington Biomedical Research Center

Eligibility 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...
  • 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (1)

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