Nicotinamide Riboside + Ketogenic Diet for Fatty Liver Disease
Trial Summary
What is the purpose of this trial?
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. ...
Will I have to stop taking my current medications?
Yes, participants must stop taking prescription medications or other drugs or supplements that may affect energy metabolism or nutrient digestion or absorption.
What data supports the effectiveness of the treatment involving a ketogenic diet and nicotinamide riboside for fatty liver disease?
Is the combination of a ketogenic diet and nicotinamide riboside safe for humans?
Research suggests that ketogenic diets, including variations like the Spanish Ketogenic Mediterranean Diet, are generally safe for treating conditions like metabolic syndrome and nonalcoholic fatty liver disease. However, specific safety data on the combination of a ketogenic diet with nicotinamide riboside is not provided in the available studies.23678
How does the treatment of Nicotinamide Riboside and Ketogenic Diet for Fatty Liver Disease differ from other treatments?
This treatment is unique because it combines Nicotinamide Riboside, a vitamin B-3 supplement that boosts NAD+ levels to improve liver health, with a Ketogenic Diet, which is high in fats and low in carbohydrates, to potentially reduce liver fat and improve metabolism. Unlike other treatments, this approach targets both cellular energy production and dietary changes to address fatty liver disease.910111213
Research Team
Stephanie T Chung, M.D.
Principal Investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria
This trial is for healthy men aged 18-65 and pre-menopausal women aged 18-50 with a BMI of 25 or more, including those with MODY2 diabetes. Participants should be weight stable and able to perform moderate cycling without heart issues. Exclusions include heavy alcohol use, liver disease indicators, significant medical conditions, drug use, certain psychological conditions, strict dietary restrictions, inability to follow study procedures or give consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Diet
Participants consume a standard high-carbohydrate diet to establish baseline measurements
Ketogenic Diet with NR or Placebo
Participants consume a ketogenic low-carb diet for 5 days, with healthy volunteers taking NR or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ketogenic Diet
- Nicotinamide Riboside
- Placebo
- Standard Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor