The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure
Recruiting now · Not applicable
Conditions studied: Obesity, Normal Physiology, Healthy Volunteers
In brief
Background: Diet-induced thermogenesis (DIT) is the amount of energy one's body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT. Objective: To learn how different diets can change a person's DIT. Eligibility: Healthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months. Design: Participants will stay in a clinic for about 35 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets. Participants will undergo multiple tests. They will be screened with blood and urine tests and a test of their heart function. During the first few days: Their waist, thigh, and neck circumference will be measured. They will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body. They will be tested for diabetes. They will answer questionnaires about topics including eating behavior, hunger, and stress. Throughout the study: Their weight will be measured daily. Blood tests will be repeated. They will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period. ...
Key facts
- Study ID
- NCT05545306
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 120
- Starts
- 2023-06-06
- Expected to finish
- 2027-02-02
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2)
- Diabetes
- i. Fasting glucose >= 126 mg/dl or hba1c >= 6.5% or
- ii. history of type 1 or type 2 diabetes
- Endocrine disorders, such as
- i. History of Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism
- ii. TSH <0.1 or >= 10 uIU/mL
- Pulmonary disorders
- i. History of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)
- Cardiovascular diseases,
- i. Including history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
- Hypertension,
- i. History of diagnosis and current treatment by an outside clinician
- ii. or sitting blood pressure measurement, using an appropriate cuff, higher than
- 140/90 mmHg
- Liver disease,
- i. including history of cirrhosis, active hepatitis B or C
- ii. AST or ALT >=3 times upper limit of normal on screening labs
- Renal disease
- i. Serum creatinine >= 1.5 mg/dls
- Abnormal kidney function (eGFR <60 mL/min/1.73m\^2)
- Central nervous system disease:
- i. including history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Cancer:
Where it is running
- NIDDK, Phoenix — Phoenix, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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