PROOF: PROtein OverFeeding Effect on Body Weight

Completed · Not applicable

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT00565149

Run by

Pennington Biomedical Research Center

People needed

60

Starts

2005-03-01

Expected to finish

2016-03-01

Last updated by the study team

2021-08-25

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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