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Study to Evaluate the Effect of Nicotinamide Riboside on Immunity

This study is currently recruiting participants.
Verified September 20, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02812238
First Posted: June 24, 2016
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
  Purpose

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

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 Intervention Phase
Atherosclerosis Diabetes Coronary Artery Disease Dietary Supplement: Nicotinamide riboside (NR) Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Study to Evaluate the Effect of Nicotinamide Riboside on Immunity

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Primary Outcome Measures:
  • The refeeding IL-1 secretion in response to inflammasome stimulation in the NR treatment arm versus the same subject's response on the placebo treatment arm using paired t-test analyses [ Time Frame: 4 weeks ]

Estimated Enrollment: 58
Study Start Date: June 23, 2016
Estimated Study Completion Date: May 31, 2018
Estimated Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Either NR at 10000mg/days/7days, followed by a washout period of 2-3 weeks, then placebo or start with placebo, followed by a 2-3 week washout period, then NR at 1000mg/day/7days
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 2-3 weeks of placebo pills.
Other: Placebo

Detailed Description:
Intermittent caloric restriction or fasting has numerous health effects including the reduction in numerous cardiovascular disease risk factors. The cellular programs activated by caloric restriction are similarly turned on in preclinical studies in response to a 24-hour fast. We have found that a beneficial effect of 24-hour fasting is that it blunts the activation of a component of the immune system, termed the Nod-like receptor family protein 3 (NLRP3) Inflammasome. This inflammasome, as a mediator of sterile inflammation, is associated with the development of diabetes and atherosclerosis. At the same time, we found that refeeding after the 24-hour fast significantly increased NLRP3 protein levels, IL-1Beta, and TNF signaling, and that fasting blunted the NLRP3 inflammasome response, in association with the activation of a fasting sensing protein called SIRT3. Interestingly, a recently discovered naturally occurring form of vitamin B3, called nicotinamide riboside (NR), has been found to activate SIRT3. We found that NR reproduces the NLRP3 inflammasome blunting effect of fasting when administered to primary human monocytes/macrophages in culture. Putting this together, it would be interesting to evaluate whether the administration of NR to human subjects would replicate the fasting blunting effect on the NLRP3 inflammasome. Interestingly, at the same time, it has recently been found, in a preclinical study, that the NLRP3 protein can orchestrate differentiation of naive T- cells into Th2 cells. We therefore propose to more broadly examine the effects of NR administration on myeloid and lymphoid cell biology in healthy volunteers.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Rebecca D Huffstutler, C.R.N.P. (301) 594-1281 rebecca.huffstutler@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Michael N Sack, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02812238     History of Changes
Other Study ID Numbers: 160129
16-H-0129
First Submitted: June 23, 2016
First Posted: June 24, 2016
Last Update Posted: October 19, 2017
Last Verified: September 20, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Inflammasome
Sirt3
Nicotinamide Riboside
Fasting

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents