Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03878108
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

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
Healthy Healthy Volunteers

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 (approximately10% of calories).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
Estimated Study Start Date : April 24, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort
1
Adults age 18-50 years.



Primary Outcome Measures :
  1. To measure the differences in ad libitum energy intake during 2 weeks of eating low- carb, high-fat (LCHF) diet compared to 2 weeks of low- fat, high- carb (LFHC) diet matched for presented caloriesand protein. [ Time Frame: ongoing ]
    LCHF diet will lead to greater mean ad libitum energy intake as compared to the LFHC diet when the meals presented to the subjects are matched for daily calories and protein.


Secondary Outcome Measures :
  1. 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 [ Time Frame: ongoing ]
    to be determined

  2. To determine differences in inflammatory markers (c- reactive protein, E-selectin, soluble intercellular adhesion molecule-1, soluble vascularadhesion molecule-1, serum amyloid A, tumor necrosis factor-a, and interleukins 6 and 8) [ Time Frame: ongoing ]
    to be determined

  3. 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. [ Time Frame: ongoing ]
    to be determined

  4. To determine changes in energy expenditure and substrate metabolism after 2 weeks of consuming a LCHF diet as compared to 2 weeks of consuming a LFHC diet matched for presented caloriesand protein. [ Time Frame: ongoing ]
    to be determined

  5. 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. [ Time Frame: ongoing ]
    to be determined



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
General Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878108


Contacts
Layout table for location contacts
Contact: Irene T Rozga, R.N. (301) 496-1069 irene.rozga@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Kevin Hall, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03878108     History of Changes
Other Study ID Numbers: 190067
19-DK-0067
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 4, 2019

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