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Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss

NCT02544009 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-04-22

No results posted yet for this study

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

Conditions

  • Energy Expenditure

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Kevin Hall, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-05
Primary Completion
2016-05-19
Completion
2016-05-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544009 on ClinicalTrials.gov