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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 : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
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Brief Summary:

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


Condition or disease
Energy Expenditure

Detailed Description:
Weight loss is accompanied by a slowing of metabolic rate. Metabolic slowing often occurs to a degree greater than predicted by the amount of weight lost, a phenomenon called metabolic adaptation , and is hypothesized to persist over time and promote weight regain. We previously discovered large metabolic adaptations in response to the intensive lifestyle intervention as part of The Biggest Loser weight loss competition. Those subjects rapidly lost massive amounts of weight and their resting energy expenditure decreased by ~500 kcal/d more than was expected based on their body composition at the end of the intervention. The purpose of this study is to investigate whether the metabolic adaptation has persisted in the years following the intervention in the same subjects. Furthermore, we will measure body weight and composition in these subjects and investigate the correlates of weight regain.
Study Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
16 subjects who previously participated in the Biggest Loser study


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This natural history study includes enrollment of 16 adult subjects who previously participated in the Biggest Loser intervention and participated in a study of body composition and metabolic changes [1]. Several years following weight loss intervention, these subjects may have experienced weight regain and either persistence or remission of the previously observed metabolic adaptation. The present study was designed to investigate the persistence of metabolic adaptation and explore whether the degree of metabolic adaptation during the weight loss intervention was correlated with body weight and body fat regain.
Criteria
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kevin Hall, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02544009    
Other Study ID Numbers: 150192
15-DK-0192
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: July 20, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Energy Expenditure
Obesity
Behavioral Weight Loss Treatment
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight