Protocol Details
Energy Intake Response to Short-Term Alterations of Energy Expenditure in Humans
This study is NOT currently recruiting participants.
Summary
Number | 17-DK-N004 |
Sponsoring Institute | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 55 Years |
Referral Letter Required | No |
Population Exclusion(s) | Non-English Speaking;
Children |
Keywords | Energy Intake;
Energy Expenditure;
Eating Behavior;
Cold Exposure;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Healthy Volunteers |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | Other: Normal temperature
Other: Fixed diet
Other: Ad libitum diet
Other: Cold exposure
Other: Fasting
|
Supporting Site | National Institute of Diabetes and Digestive and Kidney Diseases |
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.
Eligibility
INCLUSION CRITERIA: -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
EXCLUSION CRITERIA:
-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)
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT02939404