Fat Cell Size and Overfeeding and Etopic Study (EAT)

April 29, 2021 updated by: Eric Ravussin, Pennington Biomedical Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Overfeeding
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat Deposition
Time Frame: 10 Months
Viewing of adipose tissue or body fat and skeletal muscle characteristics over a period.
10 Months
Insulin Sensitivity
Time Frame: 10 months
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.
10 months
Muscle Oxidative Capacity
Time Frame: 10 Months
A measure of a muscle's maximal capacity to use oxygen in microliters of oxygen consumed per gram of muscle per hour.
10 Months
Circadian Blood Pressure variability
Time Frame: 10 Months
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.
10 Months
Resting Endothelial function testing
Time Frame: 10 Months
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®.
10 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Alok Gupta, MD, Pennington Biomedial Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 26040
  • 5R01DK060412 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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