MedDataX Logo

Trial Outcomes & Findings for Study to Evaluate the Effect of Nicotinamide Riboside on Immunity (NCT NCT02812238)

NCT ID: NCT02812238

Last Updated: 2019-09-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

4 weeks

Results posted on

2019-09-17

Participant Flow

Participant milestones

Participant milestones
Measure
Nicotinamide Riboside, Then Placebo
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.
Placebo, Then Nicotinamide Riboside
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.
First Intervention
STARTED
19
19
First Intervention
COMPLETED
18
19
First Intervention
NOT COMPLETED
1
0
Second Intervention
STARTED
18
19
Second Intervention
COMPLETED
18
18
Second Intervention
NOT COMPLETED
0
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Effect of Nicotinamide Riboside on Immunity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Subjects
n=38 Participants
Baseline data for all subjects on the study.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
24 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
11 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=5 Participants
Race (NIH/OMB)
White
15 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Nicotinamide Riboside
n=36 Participants
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.
Placebo
n=36 Participants
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.
Mean IL-1 Beta Release From Peripheral Blood Mononuclear Cells During Refeeding After 24 Hour Fast
582 mg/dL
Standard Deviation 612
794 mg/dL
Standard Deviation 941

Adverse Events

Nicotinamide Riboside

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Nicotinamide Riboside
n=38 participants at risk
These subjects were administered Nicotinamide riboside
Placebo
n=38 participants at risk
These subjects were administered Placebo
General disorders
Headache
2.6%
1/38 • 4 weeks
2.6%
1/38 • 4 weeks
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
5.3%
2/38 • 4 weeks
2.6%
1/38 • 4 weeks

Additional Information

Dr. Michael N. Sack

NHLBI

Phone: 301-402-9259

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place