NCT00565149

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

November 27, 2007

Last Update Submit

August 23, 2021

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and after 8 weeks of overfeeding

Secondary Outcomes (1)

  • 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 Arms (3)

1

EXPERIMENTAL

Normal Protein (15%) diet

Behavioral: PROOF

2

EXPERIMENTAL

Low Protein (5%) diet

Behavioral: PROOF

3

EXPERIMENTAL

High Protein (25%) diet

Behavioral: PROOF

Interventions

PROOFBEHAVIORAL

dietary overfeeding with high, low or normal protein content

Also known as: Overfeeding with different protein levels.
123

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (9)

  • 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.

    PMID: 34655863DERIVED

  • 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.

    PMID: 29374510DERIVED

  • 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.

    PMID: 29280309DERIVED

  • 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.

    PMID: 27356102DERIVED

  • 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.

    PMID: 27159194DERIVED

  • 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.

    PMID: 25733634DERIVED

  • 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.

    PMID: 25057153DERIVED

  • 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.

    PMID: 24500151DERIVED

  • 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.

    PMID: 22215165DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven R Smith, MD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Adjunct

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 29, 2007

Study Start

March 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2016

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

US(1)