Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06044935

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

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

100

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult males aged 18 to 65 years
  • Pre-menopausal adult females aged 18 to 50 years
  • Adult males or pre-menopausal adult females aged 18 to 65 or 18 to 50 years respectively with diagnosed MODY2
  • Weight stable with less than 5% change over the past 6 months
  • Body mass index of 25 kg/m2 or higher (18.5 kg/m2 or higher for MODY2 patients)
  • Able to cycle at moderate intensity with specified heart rate range and no arrhythmia
Not Eligible

You will not qualify if you...

  • Taking medications or supplements that affect energy metabolism or nutrient digestion/absorption
  • Indicators of liver disease with albumin less than 2.8 mg/mL and bilirubin over 3 mg/mL
  • Significant medical comorbidities such as non-MODY2 diabetes, severe heart failure, or advanced kidney disease
  • Taking hypertension medications if not diagnosed with MODY2
  • Participating in vigorous exercise more than 2 hours per week
  • Positive pregnancy test for those who can get pregnant
  • Hematocrit below 40% for men or below 37% for women
  • Consuming more than 300 mg caffeine per day
  • Drinking more than 3 alcoholic drinks per day for men or more than 2 for women
  • Regular tobacco, e-cigarette, nicotine patch, or illicit drug use in past 6 months
  • Psychological conditions that interfere with safe participation
  • Strict dietary restrictions or dislike of study foods
  • Unwilling or unable to comply with study procedures or availability
  • Resting energy expenditure more than 30% above or below predicted levels based on Mifflin St Jeor equation

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

N

Nan Zhai, C.R.N.P.

CONTACT

S

Stephanie T Chung, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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