Food Intake Response to Short-Term Modifications of Metabolism in Humans
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|ClinicalTrials.gov Identifier: NCT02939404|
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : July 8, 2019
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.
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.
Healthy people ages 18-55.
Participants will stay at NIH for 20 days.
During the first 4 days, participants will have:
- Medical exam
- 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. Other times, they can eat as much as they wish from a vending machine.
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Energy Intake Response to Short-Term Alterations of Energy Expenditure in Humans|
|Actual Study Start Date :||April 27, 2017|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
- To determine whether the effects of increased EE due to cool temperature exposure on energy intake are only concomitant with the increase in EE or persist until the following day. [ Time Frame: 7 yrs ]
- To investigate whether increases in EE lead to increased ad libitum food intake, as measured using a vending machine paradigm. [ Time Frame: 7 yrs ]
- To determine whether 36 hrs of fasting will result in a change in energy intake on the following day, and to determine whether the decrease in 24h EE during fasting will correlate with amount of food consumed the following day. [ Time Frame: 7 yrs ]
- To determine if the interventions will alter the 24h respiratory quotient (RQ, an approximation for the ratio of carbohydrate-to-fat oxidation rates), and test whether the induced RQ changes independently contribute to the altered energy intake. [ Time Frame: 7 yrs ]
- To determine if the 24h EE responses to cool temperature exposure correlate with core body temperature or changes in peripheral skin temperatures, and to determine if these changes are related to body adiposity or associated with food intake. [ Time Frame: 7 yrs ]
- To assess if behavioral testing addressing dietary restraint, stress related eating behaviors, and executive function or the responses to visual analogue scales assessing hunger modify any observed EE to energy intake association. [ Time Frame: 7 yrs ]
- To assess whether the above behavioral testing as measured by previously validated questionnaires and tasks are associated with measured food intake or hormone concentrations. [ Time Frame: 7 yrs ]
- To assess if concentrations of appetitive or exercise-induced hormones will correlate with the observed changes in EE and energy intake. [ Time Frame: 7 yrs ]
- To determine if any observed association between EE and energy intake predicts future weight change at 6 months and 1 year. [ Time Frame: 7 yrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939404
|Contact: Paolo Piaggi, Ph.D.||(602) email@example.com|
|United States, Arizona|
|Phoenix, Arizona, United States, 85014|
|Principal Investigator:||Paolo Piaggi, Ph.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|