Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2005-03-31
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Normal Protein (15%) diet
PROOF
dietary overfeeding with high, low or normal protein content
2
Low Protein (5%) diet
PROOF
dietary overfeeding with high, low or normal protein content
3
High Protein (25%) diet
PROOF
dietary overfeeding with high, low or normal protein content
Interventions
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PROOF
dietary overfeeding with high, low or normal protein content
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
35 Years
ALL
Yes
Sponsors
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United States Department of Agriculture (USDA)
FED
Pennington Biomedical Research Center
OTHER
Responsible Party
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Leanne Redman
Professor, Adjunct
Principal Investigators
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Steven R Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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References
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Hochsmann C, Fearnbach N, Dorling JL, Myers CA, Zhang D, Apolzan JW, Stewart TM, Bray GA, Ravussin E, Martin CK. Effect of 8 weeks of supervised overfeeding on eating attitudes and behaviors, eating disorder symptoms, and body image: Results from the PROOF and EAT studies. Eat Behav. 2021 Dec;43:101570. doi: 10.1016/j.eatbeh.2021.101570. Epub 2021 Oct 1.
Bray GA, Redman LM, de Jonge L, Rood J, Sutton EF, Smith SR. Plasma fatty acyl-carnitines during 8 weeks of overfeeding: relation to diet energy expenditure and body composition: the PROOF study. Metabolism. 2018 Jun;83:1-10. doi: 10.1016/j.metabol.2018.01.019. Epub 2018 Feb 8.
Bray GA, Redman LM, de Jonge L, Rood J, Sutton EF, Smith SR. Plasma Amino Acids During 8 Weeks of Overfeeding: Relation to Diet Body Composition and Fat Cell Size in the PROOF Study. Obesity (Silver Spring). 2018 Feb;26(2):324-331. doi: 10.1002/oby.22087. Epub 2017 Dec 27.
Sutton EF, Bray GA, Burton JH, Smith SR, Redman LM. No evidence for metabolic adaptation in thermic effect of food by dietary protein. Obesity (Silver Spring). 2016 Aug;24(8):1639-42. doi: 10.1002/oby.21541. Epub 2016 Jun 29.
Bray GA, Redman LM, de Jonge L, Rood J, Smith SR. Effect of Three Levels of Dietary Protein on Metabolic Phenotype of Healthy Individuals With 8 Weeks of Overfeeding. J Clin Endocrinol Metab. 2016 Jul;101(7):2836-43. doi: 10.1210/jc.2016-1313. Epub 2016 May 9.
Bray GA, Redman LM, de Jonge L, Covington J, Rood J, Brock C, Mancuso S, Martin CK, Smith SR. Effect of protein overfeeding on energy expenditure measured in a metabolic chamber. Am J Clin Nutr. 2015 Mar;101(3):496-505. doi: 10.3945/ajcn.114.091769. Epub 2015 Jan 14.
Gilmore LA, Ravussin E, Bray GA, Han H, Redman LM. An objective estimate of energy intake during weight gain using the intake-balance method. Am J Clin Nutr. 2014 Sep;100(3):806-12. doi: 10.3945/ajcn.114.087122. Epub 2014 Jul 23.
Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
Bray GA, Smith SR, de Jonge L, Xie H, Rood J, Martin CK, Most M, Brock C, Mancuso S, Redman LM. Effect of dietary protein content on weight gain, energy expenditure, and body composition during overeating: a randomized controlled trial. JAMA. 2012 Jan 4;307(1):47-55. doi: 10.1001/jama.2011.1918.
Other Identifiers
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2005-34323-15741
Identifier Type: -
Identifier Source: secondary_id
PBRC 25007
Identifier Type: -
Identifier Source: org_study_id
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