Study to Evaluate the Effect of Nicotinamide Riboside on Immunity
2 other identifiers
interventional
38
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2016
CompletedStudy Start
First participant enrolled
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2018
CompletedResults Posted
Study results publicly available
September 17, 2019
CompletedSeptember 17, 2019
April 3, 2019
2.2 years
June 23, 2016
August 8, 2019
August 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean IL-1 Beta Release From Peripheral Blood Mononuclear Cells During Refeeding After 24 Hour Fast
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.
4 weeks
Study Arms (2)
Arm 1
EXPERIMENTALEither 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.
Arm 2
EXPERIMENTALEither 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (5)
Traba J, Kwarteng-Siaw M, Okoli TC, Li J, Huffstutler RD, Bray A, Waclawiw MA, Han K, Pelletier M, Sauve AA, Siegel RM, Sack MN. Fasting and refeeding differentially regulate NLRP3 inflammasome activation in human subjects. J Clin Invest. 2015 Nov 3;125(12):4592-600. doi: 10.1172/JCI83260.
PMID: 26529255BACKGROUNDCanto C, Houtkooper RH, Pirinen E, Youn DY, Oosterveer MH, Cen Y, Fernandez-Marcos PJ, Yamamoto H, Andreux PA, Cettour-Rose P, Gademann K, Rinsch C, Schoonjans K, Sauve AA, Auwerx J. The NAD(+) precursor nicotinamide riboside enhances oxidative metabolism and protects against high-fat diet-induced obesity. Cell Metab. 2012 Jun 6;15(6):838-47. doi: 10.1016/j.cmet.2012.04.022.
PMID: 22682224BACKGROUNDBrown KD, Maqsood S, Huang JY, Pan Y, Harkcom W, Li W, Sauve A, Verdin E, Jaffrey SR. Activation of SIRT3 by the NAD(+) precursor nicotinamide riboside protects from noise-induced hearing loss. Cell Metab. 2014 Dec 2;20(6):1059-68. doi: 10.1016/j.cmet.2014.11.003.
PMID: 25470550BACKGROUNDHan K, Singh K, Meadows AM, Sharma R, Hassanzadeh S, Wu J, Goss-Holmes H, Huffstutler RD, Teague HL, Mehta NN, Griffin JL, Tian R, Traba J, Sack MN. Boosting NAD preferentially blunts Th17 inflammation via arginine biosynthesis and redox control in healthy and psoriasis subjects. Cell Rep Med. 2023 Sep 19;4(9):101157. doi: 10.1016/j.xcrm.2023.101157. Epub 2023 Aug 15.
PMID: 37586364DERIVEDWu J, Singh K, Lin A, Meadows AM, Wu K, Shing V, Bley M, Hassanzadeh S, Huffstutler RD, Schmidt MS, Blanco LP, Tian R, Brenner C, Pirooznia M, Kaplan MJ, Sack MN. Boosting NAD+ blunts TLR4-induced type I IFN in control and systemic lupus erythematosus monocytes. J Clin Invest. 2022 Mar 1;132(5):e139828. doi: 10.1172/JCI139828.
PMID: 35025762DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael N. Sack
- Organization
- NHLBI
Study Officials
- PRINCIPAL INVESTIGATOR
Michael N Sack, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 24, 2016
Study Start
June 23, 2016
Primary Completion
August 28, 2018
Study Completion
August 28, 2018
Last Updated
September 17, 2019
Results First Posted
September 17, 2019
Record last verified: 2019-04-03