Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

Healthy Clinical Trial

Official title:

Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878108
• Other study ID #: 190067
• Secondary ID: 19-DK-0067
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 4, 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ...

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 1, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

• INCLUSION CRITERIA:

1. Adults age 18-50 years, male and female

2. Weight stable (less than or equal to 5 % over past 6 months) as determined by volunteer report

3. Body mass index (BMI) greater that or equal to 20kg/m2

4. Body weight greater than or equal to 53 kg

5. 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:

1. Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)

2. 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)

3. Positive pregnancy test or lactation as determined by volunteer report (women only)

4. Participating in a regular exercise program (> 2h/week of vigorous activity) as determined by volunteer report

5. Hematocrit <37% (women only)

6. Hematocrit < 40% (men only)

7. Caffeine consumption > 300 mg/day as determined by volunteer report

8. 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

9. 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.

1. Past or present history of eating disorders as determined by volunteer report

2. 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

10. Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures

11. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)

12. Volunteers unwilling or unable to give informed consent

13. Non-English speakers due to unavailability of required questionnaires in other languages

Related Conditions & MeSH terms

• Healthy
• Healthy Volunteers

Intervention

Dietary Supplement:
• LCHF diet
low-carbohydrate, high-fat (LCHF)diet
• LFHC diet
low-fat, high-carbohydrate (LFHC) diet

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ad Libitum Energy Intake	Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.	14 days
Secondary	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	Day 14
Secondary	Change in Body Weight	Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)	Baseline and day 14
Secondary	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.	Baseline and day 14
Secondary	Change in Cholesterol	Change in cholesterol from baseline to day 14 for each diet	Baseline and day 14
Secondary	Change in Triglycerides	Change in triglycerides from baseline to day 14 for each diet	Baseline and day 14
Secondary	Change in TSH	Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet	Baseline and day 14
Secondary	Change in C-peptide	Change in C-peptide from baseline to day 14 for each diet	Baseline and day 14
Secondary	Change in CRP	Change in C-reactive protein (CRP) from baseline to day 14 for each diet	Baseline and day 14

External Links

•   NIH Clinical Center Detailed Web Page