CompletedNot Applicable

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

United States15 participantsStarted 2015-09-05

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

What they're measuring

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...

Timeframe: 2 weeks

Trial details

NCT IDNCT02544009

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

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2016-05-19