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Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

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ClinicalTrials.gov Identifier: NCT03878108
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date March 15, 2019
First Posted Date March 18, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date April 15, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03878108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 15, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
Official Title Effect of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism
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

...

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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population General Population
Condition
  • Healthy
  • Healthy Volunteers
Intervention Not Provided
Study Groups/Cohorts 1
Adults age 18-50 years.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 15, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Irene T Rozga, R.N. (301) 496-1069 irene.rozga@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03878108
Other Study ID Numbers 190067
19-DK-0067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators Not Provided
Investigators
Principal Investigator: Kevin Hall, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 4, 2019