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

Energy Expenditure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544009
• Other study ID #: 150192
• Secondary ID: 15-DK-0192
• Status: Completed
• Start date: September 5, 2015
• Est. completion date: May 19, 2016

Study information

• Verified date: May 9, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Energy Expenditure
• Weight Loss

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   NIH Clinical Center Detailed Web Page