- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544009
Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss
Quantifying Weight Regain and the Persistence of Metabolic Adaptation Following Extreme Weight Loss
Background:
Many people regain the weight they lose through diet and exercise. This might happen because the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may cause people to regain weight if they do not keep up high levels of exercise or major caloric restrictions. Researchers want to find the long-term effects of metabolic adaptation in the previous Biggest Loser study participants. They hope to learn the body s response to lifestyle changes that result in weight loss. They also want to see if certain changes can lead to longer-term success in maintaining weight loss.
Objectives:
To better understand the long-term metabolic changes caused by rapid weight loss achieved through diet restriction and vigorous physical activity.
Eligibility:
Former Biggest Loser research study participants (Protocol No. PBRC29008).
Design:
Participants will be screened with a phone interview.
This study has 3 phases.
Phase 1 will last at least 3 weeks. Participants will receive a physical activity monitor and wireless scale. These will send their daily weight and activity back to NIH.
In Phase 2, participants will stay at NIH for 3 days. Their metabolism will be measured through:
Their activity monitor
Urine samples and daily body weight
Medical review and physical exam
Fasting for 12 hours each night for a blood draw the following morning
DEXA: a low-dose x-ray of the body
BIS: Electrodes on the hand/wrist and foot/ankle measure body water content.
Phase 3 will last at least 3 weeks. Participants will:
Continue to monitor their daily weight and activity
Collect urine samples and send them back to NIH
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- 16 subjects who previously participated in the Biggest Loser study (Pennington Biomedical Research Center protocol no. PBRC29008).
- Written informed consent
EXCLUSION CRITERIA:
- Volunteers unwilling or unable to give informed consent.
- Women who are pregnant or breastfeeding cannot participate in the study. A pregnancy test will be performed during the first day of the inpatient visit. If the pregnancy test is positive, the subject cannot continue to participate in the study.
- Subjects with implantable cardio-defibrillator or pacemaker may not participate in the bioelectric impedance spectroscopy (BIS) testing portion of the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
16 subjects who previously participated in the Biggest Loser study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure body composition and REE several years after completion of The Biggest Loser intervention. Metabolic adaptation will be calculated as the difference between the measured REE and the REE predicted from linear regression analysis of baseli...
Time Frame: 2 weeks
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The primary analysis will use a t-test to test the null hypothesis that this difference is equal to zero.
Secondary analyses will explore predictors of metabolic adaptation.
|
2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin Hall, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications and helpful links
General Publications
- Kerns JC, Guo J, Fothergill E, Howard L, Knuth ND, Brychta R, Chen KY, Skarulis MC, Walter PJ, Hall KD. Increased Physical Activity Associated with Less Weight Regain Six Years After "The Biggest Loser" Competition. Obesity (Silver Spring). 2017 Nov;25(11):1838-1843. doi: 10.1002/oby.21986.
- Fothergill E, Guo J, Howard L, Kerns JC, Knuth ND, Brychta R, Chen KY, Skarulis MC, Walter M, Walter PJ, Hall KD. Persistent metabolic adaptation 6 years after "The Biggest Loser" competition. Obesity (Silver Spring). 2016 Aug;24(8):1612-9. doi: 10.1002/oby.21538. Epub 2016 May 2.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150192
- 15-DK-0192
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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