PROOF: PROtein OverFeeding Effect on Body Weight (PROOF)

August 23, 2021 updated by: Leanne Redman, Pennington Biomedical Research Center

Dietary Protein Content Determines Weight Gain During High Fat Overfeeding

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline and after 8 weeks of overfeeding

Secondary Outcome Measures

Outcome Measure
Time Frame
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
baseline and after 8 Weeks of over feeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

United States Department of Agriculture (USDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PBRC 25007
  • 2005-34323-15741

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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