Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate
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| ClinicalTrials.gov Identifier: NCT06044935 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : December 5, 2023
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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.
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overweight Obesity | Other: Standard Diet Other: Ketogenic Diet Dietary Supplement: Placebo Dietary Supplement: Nicotinamide Riboside | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Basic Science |
| Official Title: | Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation &Amp;Amp;Amp;Amp; Metabolic Rate |
| Estimated Study Start Date : | December 10, 2023 |
| Estimated Primary Completion Date : | January 31, 2026 |
| Estimated Study Completion Date : | January 31, 2028 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Men with overweight or obesity
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
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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 |
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Experimental: MODY2 Patients
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
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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 |
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Experimental: Women with overweight or obesity
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
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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 |
- Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet [ Time Frame: 7 days ]Mean change in sleeping energy expenditure measured by room calorimetry from 2 days of standard run-in diet to 5 days of ketogenic diet
- Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet [ Time Frame: 5 days ]Mean difference in sleeping energy expenditure measured by room calorimetry during 5 days of ketogenic diet with NR supplementation or placebo
- Mean change in sleeping fat oxidation rate between the ketogenic diet and the baseline run-in diet [ Time Frame: 7 days ]Mean change in sleeping fat oxidation measured by room calorimetry from 2 days of standard run-in diet to 5 days of ketogenic diet
- Mean difference in fat oxidation rate between NR and placebo during the ketogenic diet [ Time Frame: 5 days ]Mean difference in sleeping fat oxidation measured by room calorimetry during 5 days of ketogenic diet with NR supplementation or placebo
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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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
- 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:
An individual who meets any of the following criteria will be excluded from participation in this study:
- 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)
- 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 (females only)
- Hematocrit < 40% (men only)
- Hematocrit <37% (women only)
- Caffeine consumption > 300 mg/day as determined by volunteer report
- Alcohol consumption > 3 drinks per day for men or > 2 drinks per day for women as determined by volunteer report
- Regular use of tobacco (smoking or chewing), e-cigarettes (a.k.a. vapes), nicotine patches, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.
- Psychological conditions as determined by volunteer report such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods
- Unwilling or unable to comply with or perform all study procedures (e.g. cycling or activities of daily living), or unavailability for the duration of the study, as determined by participant or investigator discretion
- Unwilling or unable to adhere to Lifestyle Considerations throughout study duration, as determined by participant or investigator discretion
- Volunteers unwilling or unable to give informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044935
| Contact: Nan Zhai, C.R.N.P. | (301) 827-3324 | nan.zhai@nih.gov | |
| Contact: Kevin Hall, Ph.D. | (301) 402-8248 | kevinh@niddk.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: NIH Clinical Center Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 ccopr@nih.gov | |
| Principal Investigator: | Kevin Hall, Ph.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Publications:
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT06044935 |
| Other Study ID Numbers: |
10001690 001690-DK |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | December 5, 2023 |
| Last Verified: | November 28, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | .demographics, anthropometrics, indirect calorimetry data, circulating metabolites and hormones |
| Supporting Materials: |
Study Protocol Analytic Code |
| Time Frame: | Upon publication in peer reviewed journal |
| Access Criteria: | Open |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ketogenic Diet Sleep Energy Expenditure Supplement Calories |
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Overweight Overnutrition Nutrition Disorders Body Weight Niacinamide Niacin Nicotinic Acids Vitamin B Complex |
Vitamins Micronutrients Physiological Effects of Drugs Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents |