Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
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|ClinicalTrials.gov Identifier: NCT03878108|
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : April 25, 2019
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.
To better understand how low-fat and low-carbohydrate foods affect health.
Men and women ages 18 50 who have a stable body weight and can exercise daily
Participants will have a screening visit that lasts 4 6 hours. It will include:
Fasting blood and urine tests
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
|Condition or disease|
|Healthy Healthy Volunteers|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Adults age 18-50 years.
- To measure the differences in ad libitum energy intake during 2 weeks of eating low- carb, high-fat (LCHF) diet compared to 2 weeks of low- fat, high- carb (LFHC) diet matched for presented caloriesand protein. [ Time Frame: ongoing ]LCHF diet will lead to greater mean ad libitum energy intake as compared to the LFHC diet when the meals presented to the subjects are matched for daily calories and protein.
- To determine changes in oral glucose tolerance after 2 weeks of consuming a LCHF diet as compared to 2 weeks of consuming a LFHC diet matched for presented calories [ Time Frame: ongoing ]to be determined
- To determine differences in inflammatory markers (c- reactive protein, E-selectin, soluble intercellular adhesion molecule-1, soluble vascularadhesion molecule-1, serum amyloid A, tumor necrosis factor-a, and interleukins 6 and 8) [ Time Frame: ongoing ]to be determined
- To determine changes in body weight and body composition after 2 weeks of consuming a LCHF diet as compared to 2 weeks of consuming a LFHC diet matched for presented calories and protein. [ Time Frame: ongoing ]to be determined
- To determine changes in energy expenditure and substrate metabolism after 2 weeks of consuming a LCHF diet as compared to 2 weeks of consuming a LFHC diet matched for presented caloriesand protein. [ Time Frame: ongoing ]to be determined
- To determine changes in hepatic triglyceride content after 2 weeks of consuming a LCHF diet as compared to 2 weeks of consuming a LFHC diet matched for presented calories and protein. [ Time Frame: ongoing ]to be determined
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878108
|Contact: Irene T Rozga, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Kevin Hall, Ph.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|