A Study by ChromaDex to Assess the Effects of TRU NIAGEN on Cognitive Function, Mood and Sleep in Older Adults

What Was Tested

The trial (not phased) is built around NAD+.

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

Each subject will be randomly assigned to receive placebo for an 8-week treatment period. Subjects will be instructed to take two capsules (placebo) in the morning with breakfast and two capsules (placebo) in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks.

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subject is male or female, ≥55 years of age. Subject has a BMI of 18.50 to 34.99 kg/m2. Subject has a score of ≥80 on executive function at screening. One re-test will be allowed for subjects who require additional instruction on the CNS VS test battery. Subject is willing to maintain usual diet and physical activity patterns. Subject has no plans to change smoking habits during the study period.

The full record lists 11 inclusion and 22 exclusion criteria; among the exclusions: individual is currently diagnosed with dementia and/or has a score \<24 on the mini mental state questionnaire administered at visit 1 (week -1); insulin for the treatment of type i or type 2 diabetes mellitus is exclusionary; individual has uncontrolled hypertension (systolic blood pressure ≥160 mm hg and/or diastolic blood pressure ≥100 mm hg).

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

Each person switched between NAD+ and the comparison at some point, usually with a gap in between.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-06-13 with completion listed for 2019-04-26.

It ran at 1 site in United States.

Its stated primary purpose is other.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.