Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate (NCT06044935) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate
United States100 participantsStarted 2024-01-08
Plain-language summary
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.
...
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Meet one of the following:
✓. Adult males aged 18-65 years
✓. Pre-menopausal adult females aged 18-50 years
✓. 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
✓. Weight stable (\< +/- 5 % body weight change over past 6 months) as determined by volunteer report
✓. Body mass index (BMI) \>= 25 kg/m\^2 (of \>=18.5 kg/m\^2 for patients with MODY2)
✓. 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
✕. 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)
What they're measuring
1
Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet
Timeframe: 7 days
2
Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet
Timeframe: 5 days
Trial details
NCT IDNCT06044935
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
✕. Indicators of liver disease; combination of both albumin \< 2.8 mg/mL and bilirubin \> 3 mg/mL
✕. 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)
✕. Individuals taking prescription medications to treat hypertension in participants without MODY2
✕. Participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report
✕. Positive pregnancy test (only for people who can get pregnant)