An interventional study of LCHF diet and LFHC diet in Healthy and Healthy Volunteers, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Not applicable, Interventional, and Basic science
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
...
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).
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults age 18-50 years, male and female
EXCLUSION CRITERIA:
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.
Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet
Dietary Supplement: LCHF diet · Dietary Supplement: LFHC diet
Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet
Dietary Supplement: LCHF diet · Dietary Supplement: LFHC diet
low-carbohydrate, high-fat (LCHF)diet
low-fat, high-carbohydrate (LFHC) diet
Ad Libitum Energy Intake
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
Time frame: 14 days
Mean Glucose During Oral Glucose Tolerance Test (OGTT)
An OGTT was performed at the end of each 14 day period and the mean glucose was calculated
Time frame: Day 14
Change in Body Weight
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
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
Change in cholesterol from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in Triglycerides
Change in triglycerides from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in TSH
Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in C-peptide
Change in C-peptide from baseline to day 14 for each diet
Time frame: Baseline and day 14
Change in CRP
Change in C-reactive protein (CRP) from baseline to day 14 for each diet
Time frame: Baseline and day 14
| Milestone | LCHF Diet Then LFHC Diet | LFHC Diet Then LCHF Diet |
|---|---|---|
| Started | 11 | 10 |
| Completed first phase | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
| kcal per day | LC Diet | LF Diet |
|---|---|---|
| Ad Libitum Energy Intake | 2752 ± 52.0 | 2063 ± 52.0 |
An OGTT was performed at the end of each 14 day period and the mean glucose was calculated
| mg/dl | LC Diet | LF Diet |
|---|---|---|
| Mean Glucose During Oral Glucose Tolerance Test (OGTT) | 115.6 ± 2.9 | 143.3 ± 2.9 |
Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
| kg | LC Diet | LF Diet |
|---|---|---|
| Change in Body Weight | 1.77 ± 0.32 | 1.09 ± 0.32 |
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.
| kg | LC Diet | LF Diet |
|---|---|---|
| Change in Body Fat Mass | -0.18 ± 0.19 | -0.67 ± 0.19 |
Change in cholesterol from baseline to day 14 for each diet
| mg/dl | LC Diet | LF Diet |
|---|---|---|
| Change in Cholesterol | -1.25 ± 5.47 | -41.75 ± 5.47 |
Change in triglycerides from baseline to day 14 for each diet
| mg/dl | LC Diet | LF Diet |
|---|---|---|
| Change in Triglycerides | -12.1 ± 6.4 | 17.9 ± 6.4 |
Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet
| uIU/ml | LC Diet | LF Diet |
|---|---|---|
| Change in TSH | 0.082 ± 0.176 | -0.403 ± 0.176 |
Change in C-peptide from baseline to day 14 for each diet
| ng/ml | LC Diet | LF Diet |
|---|---|---|
| Change in C-peptide | -0.610 ± 0.080 | -0.250 ± 0.080 |
Change in C-reactive protein (CRP) from baseline to day 14 for each diet
| mg/l | LC Diet | LF Diet |
|---|---|---|
| Change in CRP | 0.068 ± 0.289 | -0.842 ± 0.296 |
Collected over During each 14 day diet period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LC Diet | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| LF Diet | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | LC Diet | LF Diet |
|---|---|---|
| HypoglycemiaMetabolism and nutrition disorders | 1/21 | 0/20 |
| Age, Continuous(Years) | LCHF Diet Then LFHC Diet | LFHC Diet Then LCHF Diet | Total |
|---|---|---|---|
| Mean | 28.7 ± 7.1 | 31.6 ± 5.5 | 30.1 ± 6.4 |
| Sex: Female, Male(Participants) | LCHF Diet Then LFHC Diet | LFHC Diet Then LCHF Diet | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 6 | 6 | 12 |
| Ethnicity (NIH/OMB)(Participants) | LCHF Diet Then LFHC Diet | LFHC Diet Then LCHF Diet | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 9 | 8 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LCHF Diet Then LFHC Diet | LFHC Diet Then LCHF Diet | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | LCHF Diet Then LFHC Diet | LFHC Diet Then LCHF Diet | Total |
|---|---|---|---|
| United States | 11 | 10 | 21 |
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)