- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03878108
Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
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
...
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Adults age 18-50 years, male and female
- Weight stable (less than or equal to 5 % over past 6 months) as determined by volunteer report
- Body mass index (BMI) greater that or equal to 20kg/m2
- Body weight greater than or equal to 53 kg
- Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a heart rate (HR) equal to or greater than 0.3(SqrRoot) (220-age-HRrest)+HRrest but not exceeding 0.4(SqrRoot) (220-age-HRrest)+HRrest and no signs of arrhythmia
EXCLUSION CRITERIA:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LCHF diet then LFHC diet
Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet
|
low-carbohydrate, high-fat (LCHF)diet
low-fat, high-carbohydrate (LFHC) diet
|
Active Comparator: LFHC diet then LCHF diet
Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet
|
low-carbohydrate, high-fat (LCHF)diet
low-fat, high-carbohydrate (LFHC) diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ad Libitum Energy Intake
Time Frame: 14 days
|
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Glucose During Oral Glucose Tolerance Test (OGTT)
Time Frame: Day 14
|
An OGTT was performed at the end of each 14 day period and the mean glucose was calculated
|
Day 14
|
Change in Body Weight
Time Frame: Baseline and day 14
|
Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
|
Baseline and day 14
|
Change in Body Fat Mass
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.
|
Baseline and day 14
|
Change in Cholesterol
Time Frame: Baseline and day 14
|
Change in cholesterol from baseline to day 14 for each diet
|
Baseline and day 14
|
Change in Triglycerides
Time Frame: Baseline and day 14
|
Change in triglycerides from baseline to day 14 for each diet
|
Baseline and day 14
|
Change in TSH
Time Frame: Baseline and day 14
|
Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet
|
Baseline and day 14
|
Change in C-peptide
Time Frame: Baseline and day 14
|
Change in C-peptide from baseline to day 14 for each diet
|
Baseline and day 14
|
Change in CRP
Time Frame: Baseline and day 14
|
Change in C-reactive protein (CRP) from baseline to day 14 for each diet
|
Baseline and day 14
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 190067
- 19-DK-0067 (Other Identifier: NIH Clinical Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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