Food Intake Response to Short-Term Modifications of Metabolism in Humans

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02939404

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

54

Starts

2017-04-27

Expected to finish

2024-06-24

Last updated by the study team

2025-07-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Age <18 years
• Weight greater than or equal to 204 kg (greater than or equal to 450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight <36 kg (<80 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)
• Use of medications affecting metabolism and appetite in the last three months
• Expresses unwillingness to consume all food given during the weight maintaining diet portions of the study (e.g., due to strict dietary restrictions including allergies or vegetarian or kosher diet)
• Current use of tobacco products, marijuana, amphetamines, cocaine, or intravenous drug use
• Current pregnancy, pregnancy within the past 6 months or lactation
• History or clinical manifestation of:
• Type 1 and Type 2 diabetes mellitus
• History of surgery for the treatment of obesity
• Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo and hyperthyroidism
• Pulmonary disorders, including chronic obstructive pulmonary disease
• Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
• High blood pressure by sitting blood pressure measurement using an appropriate cuff higher than 140/90 mmHg on two or more occasions, or current antihypertensive therapy
• Liver disease, including cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 2x normal
• Gastrointestinal disease including Crohn s disease, ulcerative colitis, celiac disease or other malabsorptive disorders
• Abnormal kidney function (eGFR <60 mL/min/1.73m(2))
• Central nervous system disease, including previous history of cerebrovascular accidents, dementia, neurodegenerative disorders or history of severe head trauma
• Cancer requiring treatment in the past five years, except for nonmelanoma skin cancers or cancers that have clearly been cured
• Infectious disease such as active tuberculosis, HIV (by self report), chronic coccidiomycoses or other chronic infections that might influence EE and weight
• Diagnosis of binge eating disorder, anorexia and major psychiatric disorders based upon the DSM-IV including depression, schizophrenia and psychosis, which may impact the ability of the participant to be in the respiratory chamber for 24 hour time periods
• Chronic ethanol use (more than 3 drinks/day)

Where it is running

• NIDDK, Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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