National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
NCT Number: NCT03878108
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
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Bethesda, Maryland, 20892, United States
Competing theories about obesity and its treatment contrast the relative roles of dietary fat versus carbohydrate on promotion of excessive calorie intake. Advocates of low-carbohydrate diets propose that diets high in carbohydrates lead to elevated insulin secretion and increased calorie intake. Alternatively, proponents of low-fat diets argue that diets high in fat promote passive overconsumption due to the high energy density and low satiety index of high-fat foods. Therefore, we will conduct a feeding study in 20 adult men and women to investigate the differences in ad libitum energy intake resulting from consuming two test diets for a pair of 2-week periods in a randomized, crossover design during a single 4-week inpatient period. The test diets presented to participants will be matched for calories and protein, but the low-carbohydrate diet (approximately10% of calories) will be high in fat (approximately75% of calories) whereas the low-fat diet will be high in carbohydrates (approximately75% of calories) and low in fat (approximately 10% of calories).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
low-carbohydrate, high-fat (LCHF)diet
low-fat, high-carbohydrate (LFHC) diet
Time frame: 14 days
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
Time frame: Day 14
An OGTT was performed at the end of each 14 day period and the mean glucose was calculated
Time frame: Baseline and day 14
Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
Time frame: Baseline and day 14
Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.
Time frame: Baseline and day 14
Change in cholesterol from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in triglycerides from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in C-peptide from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in C-reactive protein (CRP) from baseline to day 14 for each diet
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nih
Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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