CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Cold exposure +4 moreother
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/NCT02939404
NCT02939404N/ACompleted

Energy Intake Response to Short-Term Alterations of Energy Expenditure in Humans

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Oct 20, 2016·Updated Jul 4, 2025

In Brief

A clinical study evaluating Cold exposure, Normal temperature, and 3 other interventions for Healthy Volunteers. Completed, enrolled 54 participants across 1 site.

Detailed Summary

One reason people gain weight is eating more calories from food than what they need for energy over 24 hours. Metabolism is the amount of energy a person uses over 24 hours. Researchers want to study the relationship between changes in metabolism and how much a person eats. Objectives: To see how much food a person eats when the body's temperature is cooled. To study how changes in metabolism may alter the amount of food a person eats. Eligibility: Healthy people ages 18-55. Design: Participants will stay at NIH for 20 days. During the first 4 days, participants will have: * Medical exam * Electrocardiogram * Blood and urine tests. One blood test includes drinking a sugar solution. * DXA body composition scan * Questions about foods they like, physical activity, and personal behavior * Exercise test on a stationary bicycle Participants will spend 24-hour periods in a metabolic chamber. The chamber will be at normal room temperature or cooler. Some times, participants will eat a diet that matches their daily needs (fixed or eucaloric). Other times, they can eat as much as they wish from a vending machine (ad libitum). Participants will have blood and urine collected. Participants will swallow an ingestible wireless sensor and wear a small data recorder device. On the second to last day, participants will stay in the metabolic chamber but only consume water and non-caffeinated sugar-free beverages. Participants will come back for 1-day visits at six months and one year from the first admission. They will have blood and urine tests, and a DXA scan. They will answer questions on physical activity and food habits.

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 20, 2016
Enrollment StartApr 27, 2017
Primary CompletionJun 24, 2024
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 9.7 years ago

Interventions

Cold exposureother

23.25 hours inside respiratory chamber with the temperature set to19°C

Normal temperatureother

23.25 hours inside respiratory chamber with the temperature set to 24°C

Fixed dietother

A diet that matches the participant's caloric needs

Ad libitum dietother

Participants can eat as much as they want

Fastingother

Participants do not eat for 12 hours before and 24 hours in chamber