CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Weight Loss +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00687115
NCT00687115Phase 2Completed

Predicting Adaptive Thermogenesis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted May 30, 2008·Updated Apr 14, 2026

In Brief

A Phase 2 clinical trial evaluating Weight Loss, Overfeeding, and 1 other intervention for Obesity and 4 related conditions. Completed, enrolled 83 participants across 1 site.

Detailed Summary

This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone gains or loses weight. Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5 kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body weight less than 350 pounds (weight loss study) may be eligible for this study. The study requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week overfeeding/weight loss, 2-week post-weight change). Participants undergo the following tests and procedures during the hospital admission: * Medical history, physical examination and laboratory studies * Questionnaires to assess eating behavior, food preferences, body composition, and activity level * Body composition assessment (height, weight, waist circumference, and fat mass and muscle content through DXA and MRI scans) * Oral glucose tolerance test * Meal test to measure the response of certain hormones to food * Activity monitors to determine activity level * Metabolic chamber study to measure calories burned over 24 hours and monitor body temperature * Free-living energy use study to measure calories burned under normal home conditions over 7 days * Fat and muscle biopsies * Dietary intervention: Measurements of food intake and energy loss over a 6-week overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the subject s normal food intake) program Followup procedures after the inpatient stay: * Height and weight measurements at 6 months (overfeeding study participants) and monthly for the first year, at 3-month intervals for the second year, and then yearly for 3 more years (weight loss study participants) * Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA, oral glucose tolerance test, behavioral questionnaires and, in women who can become pregnant, pregnancy test

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2008
Enrollment StartSep 18, 2008
Primary CompletionDec 31, 2018
Study CompletionMar 20, 2023
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 18.1 years ago

Interventions

Weight Lossbehavioral

liquid diet at 50% of weight maintaining intake

Overfeedingbehavioral

Overfeeding at 150% of weight maintaining intake

Overfeeding Low Probehavioral

Overfeeding 150% of normal intake at \<5% protein