Study to Evaluate the Effect of Nicotinamide Riboside on Immunity

• Status: Completed
• Trial end date: 2018-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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.