Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate
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. ...
Conditions:
🦠 Overweight 🦠 Obesity
🗓️ Study Start (Actual) 8 January 2024
🗓️ Primary Completion (Estimated) 31 January 2026
✅ Study Completion (Estimated) 31 January 2028
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
    • 1. Meet one of the following:
    • 1. Adult males aged 18-65 years
    • 2. Pre-menopausal adult females aged 18-50 years
    • 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
    • 2. Weight stable (\< +/- 5 % body weight change over past 6 months) as determined by volunteer report
    • 3. Body mass index (BMI) \>= 25 kg/m\^2
    • 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

    Exclusion Criteria:

    • An individual who meets any of the following criteria will be excluded from participation in this study:
    • 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. Indicators of liver disease; combination of both albumin \< 2.8 mg/mL and bilirubin \> 3 mg/mL
    • 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. Individuals taking prescription medications to treat hypertension in participants without MODY2
    • 5. Participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report
    • 6. Positive pregnancy test (only for people who can get pregnant)
    • 7. Hematocrit \< 40% (men only)
    • 8. Hematocrit \<37% (women only)
    • 9. Caffeine consumption \> 300 mg/day as determined by volunteer report
    • 10. Alcohol consumption \> 3 drinks per day for men or \> 2 drinks per day for women as determined by volunteer report
    • 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. 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. 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. 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. Unwilling or unable to adhere to Lifestyle Considerations throughout study duration, as determined by participant or investigator discretion
    • 16. Volunteers unwilling or unable to give informed consent
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 19 September 2023
  • First Submitted that Met QC Criteria 19 September 2023
  • First Posted 21 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified 8 July 2024