Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss
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|ClinicalTrials.gov Identifier: NCT02544009|
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : October 14, 2021
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.
To better understand the long-term metabolic changes caused by rapid weight loss achieved through diet restriction and vigorous physical activity.
Former Biggest Loser research study participants (Protocol No. PBRC29008).
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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Quantifying Weight Regain and the Persistence of Metabolic Adaptation Following Extreme Weight Loss|
|Study Start Date :||September 5, 2015|
|Actual Primary Completion Date :||May 19, 2016|
|Actual Study Completion Date :||May 19, 2016|
16 subjects who previously participated in the Biggest Loser study
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544009
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Kevin Hall, Ph.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|