N/A
N=21
Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
Healthy · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03878108 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Ad Libitum Energy Intake — 2752; 2063 kcal per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LCHF diet (Dietary_supplement); LFHC diet (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ad Libitum Energy Intake |
2752; 2063 | — |
| SECONDARY Mean Glucose During Oral Glucose Tolerance Test (OGTT) |
115.6; 143.3 | — |
| SECONDARY Change in Body Weight |
1.77; 1.09 | — |
| SECONDARY Change in Body Fat Mass |
-0.18; -0.67 | — |
| SECONDARY Change in Cholesterol |
-1.25; -41.75 | — |
| SECONDARY Change in Triglycerides |
-12.1; 17.9 | — |
| SECONDARY Change in TSH |
0.082; -0.403 | — |
| SECONDARY Change in C-peptide |
-0.610; -0.250 | — |
| SECONDARY Change in CRP |
0.068; -0.842 | — |
Summary
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
...
Eligibility Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03878108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.