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

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.

...

Conditions

• Overweight
• Obesity

Interventions

OTHER

Standard Diet

Consisting of 15% protein, 35% fat, and 50% carbohydrate, matching the macronutrient composition of a typical American diet

OTHER

Ketogenic Diet

Consisting of a macronutrient composition of 15% protein, 80% fat, and 5% carbohydrate

DIETARY_SUPPLEMENT

Placebo

Subjects without MODY2 will take either placebo or NR (1 g BID, 2 g per day total) supplements for 7 days during this Run-in phase

DIETARY_SUPPLEMENT

Nicotinamide Riboside

Subjects without MODY2 will take either placebo or NR (1 g BID, 2 g per day total) supplements for 7 days during this Run-in phase

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-08

Primary Completion

2027-01-31

Completion

2028-01-31

Countries

• United States

Study Locations