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Nicotinamide Riboside + Ketogenic Diet for Fatty Liver Disease

N/A

Recruiting

Led By Kevin Hall, Ph.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Study Summary

This trial tests low-carb diets and a supplement called nicotinamide riboside (NR) to treat fatty liver disease in healthy adults and those with maturity-onset diabetes of the young type 2 (MODY2). Tests include physicals, 24-hr stays, high-fat shakes, activity/glucose monitors & imaging scans.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial examines the effects of a ketogenic diet and nicotinamide riboside (NR) supplement on fat usage in the body. Healthy volunteers will take NR pills for two weeks during one clinic stay and placebos during another. All participants will switch from a standard American diet to a low-carb ketogenic diet while undergoing various tests like physical exams, blood/urine tests, activity monitoring, glucose level tracking and imaging scans.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from frequent testing such as blood draws and staying seated for extended periods after consuming high-fat shakes or having substances injected. Side effects related to the NR supplement could vary since it's being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18-50 and have not gone through menopause.

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I am an adult with MODY2, male (18-65) or female (18-50) and not in menopause.

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I am a man between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet

Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet

Secondary outcome measures

Mean change in sleeping fat oxidation rate between the ketogenic diet and the baseline run-in diet

Mean difference in fat oxidation rate between NR and placebo during the ketogenic diet

Trial Design

3Treatment groups

Experimental Treatment

Group I: Women with overweight or obesityExperimental Treatment4 Interventions

To investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity

Group II: Men with overweight or obesityExperimental Treatment4 Interventions

To investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity

Group III: MODY2 PatientsExperimental Treatment3 Interventions

To measure changes in sleeping energy expenditure and fat oxidation rate after transitioning from a baseline diet to an isocaloric ketogenic diet similar to our previous study in men

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Nicotinamide Riboside

2022

N/A

~160

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,314,492 Total Patients Enrolled

446 Trials studying Obesity

588,838 Patients Enrolled for Obesity

Kevin Hall, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

10 Previous Clinical Trials

470 Total Patients Enrolled

6 Trials studying Obesity

414 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this clinical trial restricted to individuals under 80 years of age?

"This trial has a restrictive age requirement of 18 to 65 years old. As such, there are 210 studies for younger participants and 753 for those over the designated cutoff age."

Answered by AI

Who qualifies to participate in this investigation?

"To be eligible for this research, prospective participants must meet the criteria of obesity and being between 18 to 65 years old. As such, a maximum 100 individuals can enrol in this clinical trial."

Answered by AI

Are there still opportunities for eligible participants to join this investigation?

"As seen on clinicaltrials.gov, this medical trial is no longer recruiting patients. It was first posted in October of 2023 and the last update occurred in September of the same year. Nevertheless, there are still over a thousand other studies that require participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044935.

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