NCT01672632

Brief Summary

It has been shown that large fat cells are associated with more risks for insulin resistance and more cardiovascular risk factors such as high cholesterol or triglycerides.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

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

May 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

August 20, 2012

Last Update Submit

April 29, 2021

Conditions

Over Eating

Outcome Measures

Primary Outcomes (1)

  • Determine the effect of 8-weeks 40% high fat overfeeding in 40 healthy, young adults on adipose and skeletal muscle characteristics, ectopic fat accumulation, insulin sensitivity, and metabolic flexibility.

    This study will investigate how fat cell size (independent of total fat mass) affects metabolic outcomes of overfeeding, including changes in fat deposition, insulin sensitivity and muscle oxidative capacity. It has been shown that large fat cells relative to fat mass are associated with higher risks for insulin resistance and type 2 diabetes.

    10 months

Secondary Outcomes (5)

  • Fat Deposition

    10 Months

  • Insulin Sensitivity

    10 months

  • Muscle Oxidative Capacity

    10 Months

  • Circadian Blood Pressure variability

    10 Months

  • Resting Endothelial function testing

    10 Months

Study Arms (1)

Overfeeding

EXPERIMENTAL

We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.

Other: Overfeeding

Interventions

OverfeedingOTHER

We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.

Overfeeding

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Your Body Mass Index (height to weight ratio) is 22.5 to 32.5 (inclusive).
  • You are 18-40 years of age.
  • You are willing to enroll in an 8 week overfeeding study causing a 5-8 % weight gain.
  • You are willing to eat all your meals from Pennington and only meals from Pennington for approximately 10 weeks total, even when you are full. Prior to overfeeding 2 Meals per day will be served at Pennington with lunch packed for at least 7 days. After that time participants will receive and eat all (overfeeding) meals at PBRC for 8 weeks. Post-overfeeding will consists of weight-maintenance diet for 1 week. All meals will be monitored at Pennington.
  • You are willing to maintain the same level of exercise after enrollment in the study throughout the length of the study.
  • You are willing to complete nutritional and activity questionnaires.

You may not qualify if:

  • You weight \> 300 lbs
  • You have a history of cardiovascular disease or diabetes.
  • You have a fasting blood glucose \> 110 mg/dL.
  • You have an average screening blood pressure \> 140/90.
  • You have liver disease.
  • You have thyroid disease.
  • Have Acid Reflux
  • Had cancer in the last 5 years (Some skin cancers OK)
  • Have HIV
  • Have had an Eating Disorders
  • You are pregnant or breastfeeding.
  • You have gained or lost more than 3kg in the last 3 months
  • You require chronic use of medications including diuretics, steroids and adrenergic-stimulating agents.
  • You or a member of your family has a history of blood clots (deep vein thrombosis or pulmonary embolism)
  • You have poor circulation, history of bypass operation in your legs, blood coagulation disorders, diagnosed peripheral arterial or vascular disease, cramping pain in your leg muscle during exercise or nerve damage to your legs
  • +6 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 (12)

  • White U, Beyl RA, Ravussin E. A higher proportion of small adipocytes is associated with increased visceral and ectopic lipid accumulation during weight gain in response to overfeeding in men. Int J Obes (Lond). 2022 Aug;46(8):1560-1563. doi: 10.1038/s41366-022-01150-y. Epub 2022 May 23.

    PMID: 35599261DERIVED

  • 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

  • Johannsen DL, Marlatt KL, Conley KE, Smith SR, Ravussin E. Metabolic adaptation is not observed after 8 weeks of overfeeding but energy expenditure variability is associated with weight recovery. Am J Clin Nutr. 2019 Oct 1;110(4):805-813. doi: 10.1093/ajcn/nqz108.

    PMID: 31204775DERIVED

  • Broskey NT, Obanda DN, Burton JH, Cefalu WT, Ravussin E. Skeletal muscle ceramides and daily fat oxidation in obesity and diabetes. Metabolism. 2018 May;82:118-123. doi: 10.1016/j.metabol.2017.12.012. Epub 2018 Jan 4.

    PMID: 29307520DERIVED

  • Toledo FGS, Johannsen DL, Covington JD, Bajpeyi S, Goodpaster B, Conley KE, Ravussin E. Impact of prolonged overfeeding on skeletal muscle mitochondria in healthy individuals. Diabetologia. 2018 Feb;61(2):466-475. doi: 10.1007/s00125-017-4496-8. Epub 2017 Nov 17.

    PMID: 29150696DERIVED

  • Covington JD, Johannsen DL, Coen PM, Burk DH, Obanda DN, Ebenezer PJ, Tam CS, Goodpaster BH, Ravussin E, Bajpeyi S. Intramyocellular Lipid Droplet Size Rather Than Total Lipid Content is Related to Insulin Sensitivity After 8 Weeks of Overfeeding. Obesity (Silver Spring). 2017 Dec;25(12):2079-2087. doi: 10.1002/oby.21980. Epub 2017 Oct 25.

    PMID: 29071793DERIVED

  • Heymsfield SB, Peterson CM, Thomas DM, Hirezi M, Zhang B, Smith S, Bray G, Redman L. Establishing energy requirements for body weight maintenance: validation of an intake-balance method. BMC Res Notes. 2017 Jun 26;10(1):220. doi: 10.1186/s13104-017-2546-4.

    PMID: 28651559DERIVED

  • Peterson CM, Orooji M, Johnson DN, Naraghi-Pour M, Ravussin E. Brown adipose tissue does not seem to mediate metabolic adaptation to overfeeding in men. Obesity (Silver Spring). 2017 Mar;25(3):502-505. doi: 10.1002/oby.21721. Epub 2017 Jan 24.

    PMID: 28117556DERIVED

  • Covington JD, Noland RC, Hebert RC, Masinter BS, Smith SR, Rustan AC, Ravussin E, Bajpeyi S. Perilipin 3 Differentially Regulates Skeletal Muscle Lipid Oxidation in Active, Sedentary, and Type 2 Diabetic Males. J Clin Endocrinol Metab. 2015 Oct;100(10):3683-92. doi: 10.1210/JC.2014-4125. Epub 2015 Jul 14.

    PMID: 26171795DERIVED

  • 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

  • Johannsen DL, Tchoukalova Y, Tam CS, Covington JD, Xie W, Schwarz JM, Bajpeyi S, Ravussin E. Effect of 8 weeks of overfeeding on ectopic fat deposition and insulin sensitivity: testing the "adipose tissue expandability" hypothesis. Diabetes Care. 2014 Oct;37(10):2789-97. doi: 10.2337/dc14-0761. Epub 2014 Jul 10.

    PMID: 25011943DERIVED

  • 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

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Ravussin, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

  • Alok Gupta, MD

    Pennington Biomedial Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 27, 2012

Study Start

May 1, 2008

Primary Completion

February 1, 2012

Study Completion

December 1, 2020

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

US(1)