Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

Completed · Not applicable

Conditions studied: Healthy, Healthy Volunteers

In brief

Background: Researchers want to learn how different diets affect hormone levels, body weight, energy expenditure, liver fat, and more. To do this, they will use specialized techniques and food plans. This is not a weight loss study. Objective: To better understand how low-fat and low-carbohydrate foods affect health. Eligibility: Men and women ages 18-50 who have a stable body weight and can exercise daily Design: Participants will have a screening visit that lasts 4-6 hours. It will include: Medical history Physical exam Fasting blood and urine tests Questionnaires Trying foods from the study Participants will be admitted to the Clinical Center and will stay for 4 weeks without leaving. They can have visitors. Participants will wear activity and glucose monitors throughout the study. They will be weighed daily and will complete daily exercise. They will eat 3 meals daily, plus snacks. They will give urine, saliva, and blood samples. They will fill out questionnaires and rate their hunger, appetite, and sense of taste. They will have body scans. For the scans, they will lie in a machine that takes X-ray pictures of the body. Participants will complete activities to measure how many calories they burn and how the diets affect them: Participants will drink special liquids to measure calories burned, sugar, and sense of taste. Participants will wear a plastic hood while resting. Participants will stay alone in a special room for 24 hours. Participants will eat a low-carb, high-fat diet for 2 weeks and a high-carb, low-fat diet for 2 weeks. Participants may be dismissed if they purposefully use the study to try to change their body weight. Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases ...

Key facts

Study ID

NCT03878108

Run by

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

People needed

21

Starts

2019-04-15

Expected to finish

2020-09-01

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
• Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
• Positive pregnancy test or lactation as determined by volunteer report (women only)
• Participating in a regular exercise program (> 2h/week of vigorous activity) as determined by volunteer report
• Hematocrit <37% (women only)
• Hematocrit < 40% (men only)
• Caffeine consumption > 300 mg/day as determined by volunteer report
• Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months as determined by volunteer report
• Psychological conditions such as (but not limited to) eating disorders, claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators.
• Past or present history of eating disorders as determined by volunteer report
• Past or present history of claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry and being in an MRI scanner for liver fat measures
• Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures
• Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
• Volunteers unwilling or unable to give informed consent
• Non-English speakers due to unavailability of required questionnaires in other languages

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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