Study to Evaluate the Effect of Nicotinamide Riboside on Immunity
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|ClinicalTrials.gov Identifier: NCT02812238|
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : June 15, 2018
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.
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.
Healthy volunteers ages 18 39
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) Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Study to Evaluate the Effect of Nicotinamide Riboside on Immunity|
|Study Start Date :||June 23, 2016|
|Estimated Primary Completion Date :||March 5, 2019|
|Estimated Study Completion Date :||March 5, 2019|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812238
|Contact: Rebecca D Huffstutler, C.R.N.P.||(301) email@example.com|
|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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Michael N Sack, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|