Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

• ClinicalTrials.gov Identifier: NCT03878108
• Recruitment Status: Completed
• First Posted: March 18, 2019
• Last Update Posted: February 11, 2021
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description

Brief 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

...

Condition or disease	Intervention/treatment	Phase
Healthy; Healthy Volunteers	Dietary Supplement: LCHF diet; Dietary Supplement: HCLF diet	Not Applicable

Detailed 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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
• Actual Study Start Date: April 15, 2019
• Actual Primary Completion Date: March 4, 2020
• Actual Study Completion Date: September 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: HCLF diet; high-carbohydrate, low-fat (HCLF) diet.	Dietary Supplement: HCLF diet; high-carbohydrate, low-fat (HCLF) diet
Active Comparator: LCHF diet; low-carbohydrate, high-fat (LCHF)diet	Dietary Supplement: LCHF diet; low-carbohydrate, high-fat (LCHF)diet

Outcome Measures

Primary Outcome Measures :

1. To measure the differences in ad libitum energy intake during 2 weeks of eating lowcarb, high-fat (LCHF) diet compared to 2 weeks of lowfat, high- carb (LFHC) diet matched for presented calories and protein. [ Time Frame: 4 weeks ]
   To measure the differences in ad libitum energy intake during 2 weeks of eating lowcarb, high-fat (LCHF) diet compared to 2 weeks of lowfat, high- carb (LFHC) diet matched for presented calories and protein.

Secondary Outcome Measures :

1. Oral glucose tolerance test [ Time Frame: 4 weeks ]
   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
2. inflammatory markers measure [ Time Frame: 4 weeks ]
   To determine differences in inflammatory markers after 2 weeks of consuming a LCHF diet as compared to 2 weeks of consuming a LFHC diet matched for presented calories and protein.
3. Measure body weight and body composition [ Time Frame: 4 weeks ]
   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.
4. Measure energy expenditure and substrate metabolism [ Time Frame: 4 weeks ]
   To determine changes in energy expenditure andsubstrate metabolism after 2 weeks of consuming a LCHF diet as compared to 2 weeks of consuming a LFHC diet matched for presented calories and protein.
5. Measure changes in hepatic triglyceride content [ Time Frame: 4 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

• INCLUSION CRITIERIA:

  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 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

Contacts and Locations

Locations

United States, Maryland

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Kevin Hall, Ph.D.; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hall KD, Guo J, Courville AB, Boring J, Brychta R, Chen KY, Darcey V, Forde CG, Gharib AM, Gallagher I, Howard R, Joseph PV, Milley L, Ouwerkerk R, Raisinger K, Rozga I, Schick A, Stagliano M, Torres S, Walter M, Walter P, Yang S, Chung ST. Effect of a plant-based, low-fat diet versus an animal-based, ketogenic diet on ad libitum energy intake. Nat Med. 2021 Feb;27(2):344-353. doi: 10.1038/s41591-020-01209-1. Epub 2021 Jan 21.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT03878108
• Other Study ID Numbers: 190067; 19-DK-0067
• First Posted: March 18, 2019
• Last Update Posted: February 11, 2021
• Last Verified: December 4, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):

Accelerometry; Body Composition; Body Weight Regulation; Calories; Energy Expenditure