Energy Expenditure Clinical Trial
Official title:
Quantifying Weight Regain and the Persistence of Metabolic Adaptation Following Extreme Weight Loss
Verified date | May 9, 2024 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 15 |
Est. completion date | May 19, 2016 |
Est. primary completion date | May 19, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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... | 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 |
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