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

NCT02939404 | Completed Results

• 2 other identifiers: 99991700417-DK-N004
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Energy Intake; Energy Expenditure; Eating Behavior; Cold Exposure; Natural History

Outcome Measures

Primary Outcomes (2)

• 24-hour Energy Expenditure (kcal)

  Energy expenditure (EE) as measured during 24 hours in a whole-room calorimeter

  Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)

• 24-hour Energy Intake (kcal)

  Energy intake as measured during 24 hours in a whole-room calorimeter

  Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)

Secondary Outcomes (8)

• 24- Hour Respiratory Quotient (RQ)

  Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)

• Leptin

  Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)

• Secretin

  Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)

• Ghrelin

  Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)

• FGF-21

  Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)

Study Arms (5)

1. Chamber at 24C, fixed diet

EXPERIMENTAL

Chamber at room temperature (24C) with a fixed eucaloric diet

Other: Normal temperature; Other: Fixed diet

2. Chamber at 24C, ad libitum diet

EXPERIMENTAL

Chamber at room temperature (24C) with an ad libitum diet (self-select how much food they wish to eat)

Other: Normal temperature; Other: Ad libitum diet

3. Chamber at 19C, fixed diet

EXPERIMENTAL

Chamber at cold temperature (16C) with a fixed eucaloric diet

Other: Cold exposure; Other: Fixed diet

4. Chamber at 19C, ad libitum diet

EXPERIMENTAL

Chamber at cold temperature (19C) with an ad libitum diet (self-select how much food they wish to eat)

Other: Cold exposure; Other: Ad libitum diet

5. Chamber at 24C, fasting

EXPERIMENTAL

Chamber at room temperature (24C) fasting while in chamber and 12 hours before

Other: Normal temperature; Other: Fasting

Interventions

Cold exposure OTHER

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

3. Chamber at 19C, fixed diet; 4. Chamber at 19C, ad libitum diet

Normal temperature OTHER

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

1. Chamber at 24C, fixed diet; 2. Chamber at 24C, ad libitum diet; 5. Chamber at 24C, fasting

Fixed diet OTHER

A diet that matches the participant's caloric needs

Also known as: Eucaloric diet

1. Chamber at 24C, fixed diet; 3. Chamber at 19C, fixed diet

Ad libitum diet OTHER

Participants can eat as much as they want

2. Chamber at 24C, ad libitum diet; 4. Chamber at 19C, ad libitum diet

Fasting OTHER

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

5. Chamber at 24C, fasting

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women and men \<55 years of age
• Body weight \<204 kg (\<450 pounds) and \>= 36 kg (\>= 80 pounds)
• Stable weight (+/-5% within past 6 months) as determined by volunteer report
• Healthy, as determined by medical history, physical examination, and laboratory tests

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (3)

• Unlu Y, Piaggi P, Stinson EJ, De Baca TC, Rodzevik TL, Walter M, Fry H, Krakoff J, Chang DC. Cold induces increased ad libitum energy intake independent of changes in energy expenditure: a controlled crossover trial in adults. Am J Clin Nutr. 2025 Feb;121(2):293-303. doi: 10.1016/j.ajcnut.2024.12.013. Epub 2024 Dec 14.

  PMID: 39675563 DERIVED

• Hollstein T, Heinitz S, Ando T, Rodzevik TL, Basolo A, Walter M, Chang DC, Krakoff J, Piaggi P. Metabolic Responses to 24-Hour Fasting and Mild Cold Exposure in Overweight Individuals Are Correlated and Accompanied by Changes in FGF21 Concentration. Diabetes. 2020 Jul;69(7):1382-1388. doi: 10.2337/db20-0153. Epub 2020 Apr 27.

  PMID: 32341039 DERIVED

• Hollstein T, Basolo A, Ando T, Votruba SB, Walter M, Krakoff J, Piaggi P. Recharacterizing the Metabolic State of Energy Balance in Thrifty and Spendthrift Phenotypes. J Clin Endocrinol Metab. 2020 May 1;105(5):1375-92. doi: 10.1210/clinem/dgaa098.

  PMID: 32118268 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Results Point of Contact

• Title: Douglas C. Chang, MD
• Organization: Obesity & Diabetes Clinical Research Section, NIDDK

Douglas.Chang@nih.gov

602.200.5312

Study Officials

• Douglas Chang, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 20, 2016
• Study Start: April 27, 2017
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2024-07-03

Locations

US (1)