RECRUITING

Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate

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Conditions

OverweightObesityKetogenic DietSleepEnergy ExpenditureSupplementCalories

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: At least 30% of Americans have fatty liver disease. This means that they store too much fat in the liver. At the moment lifestyle changes are the only way to treat this problem. Objective: To test how (1) a low-carbohydrate diet and (2) a supplement called nicotinamide riboside (NR) affect how a person s body uses dietary fat. Eligibility: Men aged 18 to 65 and women aged 18 to 50 who are healthy volunteers with a body mass index (height to weight ratio) of 25 or more. Adults with maturity-onset diabetes of the young type 2 (MODY2) are also needed. Design: Participants with diabetes will have 1 screening visit and a 9-day clinic stay. Healthy volunteers will have 1 screening visit and 2 clinic stays of 1 to 2 weeks each. During screening, all participants will have a physical exam with blood and urine tests. They will have their heart rhythm measured while riding a gym bike. NR is a pill taken by mouth. Only healthy volunteers will take the NR, for 14 days at a time, during 1 clinic stay. During their other stay, they will take placebos; these are pills that look like the study supplement but contain no NR. During each clinic stay, all participants will eat a normal American diet. Then they will eat a ketogenic "low-carb" diet for 5 days. Participants will have many tests, including: Sleeping every night and having two 24-hour stays in a special room that measures the gases their body uses and produces. Drinking a high-fat shake, then remaining seated for 5 hours while their blood and breath are monitored. Having a substance injected into the arm and remaining seated for 3 hours while their blood is measured. Wearing monitors to measure their activity levels. Another monitor will measure their blood glucose levels. Having imaging scans. ...

Official Title

Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation &Amp;Amp;Amp;Amp; Metabolic Rate

Quick Facts

Study Start:2024-01-08
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06044935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Meet one of the following:
  2. 1. Adult males aged 18-65 years
  3. 2. Pre-menopausal adult females aged 18-50 years
  4. 3. Adult males aged 18-65 years with diagnosed maturity-onset diabetes of the young type 2 (MODY2) or pre-menopausal adult females aged 18-50 years with diagnosed MODY2
  5. 2. Weight stable (\< +/- 5 % body weight change over past 6 months) as determined by volunteer report
  6. 3. Body mass index (BMI) \>= 25 kg/m\^2 (of \>=18.5 kg/m\^2 for patients with MODY2)
  7. 4. Able to cycle at a moderate rate and intensity with a HR equal to or greater than 0.3x(220-age-HRrest)+HRrest but not exceeding 0.4x(220-age-HRrest)+HRrest with no signs of arrhythmia
  1. 1. Taking prescription medications or other drugs or supplements that may influence energy metabolism or nutrient digestion or absorption (including, but not limited to, diet/weight-loss medication or other medications at the discretion of the PI and/or study team)
  2. 2. Indicators of liver disease; combination of both albumin \< 2.8 mg/mL and bilirubin \> 3 mg/mL
  3. 3. Individuals with significant medical comorbidities (e.g., non-MODY2 diabetes, NYHA Class \>II heart failure, or CKD Stage II or worse, or American Society of Anesthesiologists Physical Status Class 3 or above)
  4. 4. Individuals taking prescription medications to treat hypertension in participants without MODY2
  5. 5. Participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report
  6. 6. Positive pregnancy test (only for people who can get pregnant)
  7. 7. Hematocrit \< 40% (men only)
  8. 8. Hematocrit \<37% (women only)
  9. 9. Caffeine consumption \> 300 mg/day as determined by volunteer report
  10. 10. Alcohol consumption \> 3 drinks per day for men or \> 2 drinks per day for women as determined by volunteer report
  11. 11. Regular use of tobacco (smoking or chewing), e-cigarettes (a.k.a. vapes), nicotine patches, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.
  12. 12. Psychological conditions as determined by volunteer report such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators
  13. 13. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods
  14. 14. Unwilling or unable to comply with or perform all study procedures (e.g. cycling or activities of daily living), or unavailability for the duration of the study, as determined by participant or investigator discretion
  15. 15. Unwilling or unable to adhere to Lifestyle Considerations throughout study duration, as determined by participant or investigator discretion
  16. 16. Volunteers unwilling or unable to give informed consent
  17. 17. Participants with a measured Resting Energy Expenditure (REE) more than 30% above or below the predicted REE based on Mifflin St Jeor equation

Contacts and Locations

Study Contact

Nan Zhai, C.R.N.P.
CONTACT
(301) 827-3324
nan.zhai@nih.gov
Stephanie T Chung, M.D.
CONTACT
(240) 479-8137
stephanie.chung@nih.gov

Principal Investigator

Stephanie T Chung, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

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

  • Stephanie T Chung, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

  • Ketogenic Diet
  • Sleep
  • Energy Expenditure
  • Supplement
  • Calories

Additional Relevant MeSH Terms

  • Overweight
  • Obesity