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Over EatingEATNCT01672632

Fat Cell Size and Overfeeding and Etopic Study

A study testing Overfeeding in people with Over Eating, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Over Eating
What is being tested?
Overfeeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
May 2008to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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
  • You have varicose veins (per discretion of MD or NP)
  • You have had previous GI surgery, obstructive disease of the GI tract, hyper motility disorder or a history of problems of impairment of the gag reflex.
  • You have emotional problems such as clinical depression or other diagnosed psychological conditions.
  • You are claustrophobic.
  • You have metal objects in your body such as implanted rods or surgical clips or magnetic objects that are incompatible with the MRI/MRS.
  • You smoke or use tobacco products

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

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.

Read the detailed description

This study will look at fat cell size and how it affects fat deposition, insulin resistance and muscle oxidative capacity. A comparison will be made with the differences between participants with larger versus smaller fat cells in insulin resistance and blood levels of lipids. The study will also determine if characteristics of fat cells and muscle can predict the development of weight gain-induced insulin resistance.

Conditions
Over Eating
Being tested
Overfeeding
Medical subject headings
Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01672632
Study groupRoleWhat they receive
OverfeedingExperimentalWe 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.
Receives: Other: Overfeeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 months

Secondary outcomes (5)

  1. Fat Deposition

    Viewing of adipose tissue or body fat and skeletal muscle characteristics over a period.

    Measured: 10 Months

  2. Insulin Sensitivity

    Measure and monitor the natural hormone insulin becomes less effective at lowering blood sugars. The resulting increase in blood glucose may raise levels outside the normal range and cause adverse heealth effects, depending on dietary conditions or sensitivity of cells to insulin.

    Measured: 10 months

  3. Muscle Oxidative Capacity

    A measure of a muscle's maximal capacity to use oxygen in microliters of oxygen consumed per gram of muscle per hour.

    Measured: 10 Months

  4. Circadian Blood Pressure variability

    Blood pressure and heart rate measurement: An automatic BP monitoring device (Mortara® Ambulo 2400) for ambulatory use was attached to a BP cuff to obtain blood pressure (BP) and heart rate (HR) readings at 30-min intervals during the day (6:30 AM to 9:30 PM) and 60-min intervals at night (10 PM to 6 AM) while the participants went about their activities. Data were downloaded into the database at the end of the 7-day recording span for a chronobiological analysis. This was done at baseline, post-overfeeding and at 3 months.

    Measured: 10 Months

  5. Resting Endothelial function testing

    Endothelial function testing: Assessment of resting endothelial function was done with the participant in a fasting state, after having avoided stimulants (caffeine, tobacco, alcohol, exercise) for 12 hours, at the same fixed clock hour (range 8-10 AM), using the EndoPAT 2000 device manufactured by ITAMAR Medical®.

    Measured: 10 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2012 (estimated)
  2. Study startMay 2008
  3. Primary completionFeb 2012
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01672632
Sponsor's protocol ID
PBRC 26040
Other IDs
5R01DK060412
Acronym
EAT
Status last verified
Apr 2021
First submitted
20 Aug 2012
Last updated
3 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35599261

  • 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.

    PubMed 34655863

  • 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.

    PubMed 31204775

  • 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.

    PubMed 29307520

  • 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.

    PubMed 29150696

  • 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.

    PubMed 29071793

  • 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.

    PubMed 28651559

  • 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.

    PubMed 28117556

  • 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.

    PubMed 26171795

  • 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.

    PubMed 25057153

  • 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.

    PubMed 25011943

  • 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.

    PubMed 24500151

Questions about this trial

What is this clinical trial studying?

A study testing Overfeeding in people with Over Eating, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01672632, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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