Study to Evaluate the Effect of Nicotinamide Riboside on Immunity
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02812238 |
Recruitment Status :
Completed
First Posted : June 24, 2016
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Background:
The immune system controls how the body responds to infection or injury. Researchers want to see what effect a dietary supplement called nicotinamide riboside (NR) has on the immune system. A study showed that fasting has a good effect on immune cell health in healthy people. And when immune cells were exposed to NR they had a similar positive response as with fasting. Researchers want to see if healthy people have the same effects from NR and fasting, and if those effects last.
Objectives:
To see if taking nicotinamide riboside will have the same healthy immune system effects as fasting. To see if these good effects continue even after eating again.
Eligibility:
Healthy volunteers ages 18 - 39 years
Design:
Participants will be screened with medical history, physical exam, and blood tests. Women will have a urine pregnancy test.
Participants will take 4 pills of either NR or a placebo once a day for 1 week.
On day 6, they will not eat or drink anything.
On day 7, they will have a study visit to give a blood sample before and after eating a meal at the clinic.
They will also give a urine sample.
Participants will stop taking the pills for 1 2 weeks.
Participants will take either NR or a placebo once a day for 1 week.
They will repeat day 6 and day 7 of the first week.
Participants will get NR once and placebo once, but will not know which they are taking.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis Diabetes Coronary Artery Disease | Dietary Supplement: Nicotinamide riboside (NR) Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Study to Evaluate the Effect of Nicotinamide Riboside on Immunity |
Study Start Date : | June 23, 2016 |
Actual Primary Completion Date : | August 28, 2018 |
Actual Study Completion Date : | August 28, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
Either NR at 1000mg/day or placebo for one week, followed by a washout period of 2-3 weeks, then a crossover to placebo or NR at 1000mg/day for one additional week. The end point was analyzed at end of each treatment.
|
Dietary Supplement: Nicotinamide riboside (NR)
NR at dose of 1000mg/day will be given for a period of 7 days in a double blinded fashion either from the start of tx or after 1 week of placebo pills. Drug: Placebo Placebo capsule daily for a period of 7 days in a double blinded fashion either from the start of tx or after 1 week of NR at a dose of 1000mg/day. |
Experimental: Arm 2
Either NR at 1000mg/day or placebo for one week, followed by a washout period of 2-3 weeks, then a crossover to placebo or NR at 1000mg/day for one additional week. The end point was analyzed at end of each treatment.
|
Dietary Supplement: Nicotinamide riboside (NR)
NR at dose of 1000mg/day will be given for a period of 7 days in a double blinded fashion either from the start of tx or after 1 week of placebo pills. Drug: Placebo Placebo capsule daily for a period of 7 days in a double blinded fashion either from the start of tx or after 1 week of NR at a dose of 1000mg/day. |
- Mean IL-1 Beta Release From Peripheral Blood Mononuclear Cells During Refeeding After 24 Hour Fast [ Time Frame: 4 weeks ]The IL- 1beta secretion is measured in response to fasting, refeeding and administration of Nicotinamide Riboside (or placebo). Nicotinamide riboside acts as a fasting mimetic, and is supposed to maintain the reduction of IL-1 beta secretion (indicating NLRP3 inflammasome activation) induced by fasting. 1000 mg of Nicotinamide riboside on a daily basis is given to the subjects for a period of 7-10 days.

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 39 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
As this is a pilot study, the age-range and BMI range of subjects will be restricted to potentially reduce metabolic variables associated with a wide age- and BMI-range.
- Males and females between the ages of 18 and 39
- BMI between 18.5 and 29.9
- Agrees to comply with study procedures and maintain current level of physical activity and dietary intake throughout the study.
- Female subjects of child-bearing ability willing to commit to reliable contraception while participating in the study.
EXCLUSION CRITERIA:
- Subjects with an acute or chronic illness as per history, on laboratory analysis or requiring medications to manage disease.
- Subjects taking vitamins or supplements or any medications, except oral contraceptives, within 4 weeks of participation into this study.
- BMI <18.5 or >29.9.
- Female subjects who are pregnant or lactating.
- Subjects who have donated blood or participated in another clinical trial involving blood draws in the last 8 weeks.
- Subjects who use nicotine products including chewing tobacco, vaporizer, gum, cigarette or patch form within three months.
- Any other medical condition that, in the opinion of the Principal Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.

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): NCT02812238
United States, Maryland | |
National Institutes of Health Clinical Center | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Michael N Sack, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Documents provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT02812238 |
Other Study ID Numbers: |
160129 16-H-0129 |
First Posted: | June 24, 2016 Key Record Dates |
Results First Posted: | September 17, 2019 |
Last Update Posted: | September 17, 2019 |
Last Verified: | April 3, 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Inflammasome Sirt3 Nicotinamide Riboside Fasting |
Niacinamide Niacin Nicotinic Acids Coronary Artery Disease Atherosclerosis Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents |