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Study to Evaluate the Effect of Nicotinamide Riboside on Immunity

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ClinicalTrials.gov Identifier: NCT02812238
Recruitment Status : Completed
First Posted : June 24, 2016
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Atherosclerosis
Diabetes
Coronary Artery Disease
Interventions Dietary Supplement: Nicotinamide riboside (NR)
Drug: Placebo
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nicotinamide Riboside, Then Placebo Placebo, Then Nicotinamide Riboside
Hide Arm/Group Description These subjects were first administered Nicotinamide riboside at 1000mg/day or placebo for one week, followed by a washout period of 2-3 weeks, then a crossover to placebo for one additional week. These subjects were first administered Placebo for one week, followed by a washout period of 2-3 weeks, then a crossover to Nicotinamide riboside at 1000mg/day for one week.
Period Title: First Intervention
Started 19 19
Completed 18 19
Not Completed 1 0
Period Title: Second Intervention
Started 18 19
Completed 18 18
Not Completed 0 1
Arm/Group Title All Subjects
Hide Arm/Group Description Baseline data for all subjects on the study.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
38
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
24
  63.2%
Male
14
  36.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
34
  89.5%
Unknown or Not Reported
4
  10.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
11
  28.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  21.1%
White
15
  39.5%
More than one race
1
   2.6%
Unknown or Not Reported
3
   7.9%
1.Primary Outcome
Title Mean IL-1 Beta Release From Peripheral Blood Mononuclear Cells During Refeeding After 24 Hour Fast
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotinamide Riboside Placebo
Hide Arm/Group Description:
In this crossover design the study subjects from both arms that had received NR at 1000mg/days/7days, were combined to analyze the effect of NR on IL-1beta secretion in response to refeeding.
In this crossover design the study subjects from both arms that had received placebo for days, were combined to analyze the effect of NR on IL-1beta secretion in response to refeeding.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: mg/dL
582  (612) 794  (941)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nicotinamide Riboside Placebo
Hide Arm/Group Description These subjects were administered Nicotinamide riboside These subjects were administered Placebo
All-Cause Mortality
Nicotinamide Riboside Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Hide Serious Adverse Events
Nicotinamide Riboside Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nicotinamide Riboside Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/38 (7.89%)   2/38 (5.26%) 
General disorders     
Headache   1/38 (2.63%)  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection   2/38 (5.26%)  1/38 (2.63%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael N. Sack
Organization: NHLBI
Phone: 301-402-9259
EMail: sackm@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT02812238    
Other Study ID Numbers: 160129
16-H-0129
First Submitted: June 23, 2016
First Posted: June 24, 2016
Results First Submitted: August 8, 2019
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019