Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET)

What Was Tested

The trial (phase 1) is built around NAD+.

It had two arms (groups): Basis (experimental) and Placebo (placebo comparator).

Placebo given twice daily for 90 days.

The registry classes the interventions as dietary supplement.

More on the Plan

Elderly trauma patients who present after a traumatic injury will be screened and enrolled within 48 hours of their trauma evaluation.

Baseline status will be determined using functional surveys, physical assessments, and physiologic measurements.

Patients will be randomized to either BasisTM or placebo for 90 days.

Patients will be reassessed at 2 weeks, 6 weeks (optional) and 90 days.

Who Took Part

48 planned participants were the target.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: ≥ 65 year old. Patient presenting to trauma bay.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: currently taking medication for severe to moderate dementia (see appendix 9); currently taking niacin, nicotinic acid, nicotinamide, or nicotinamide riboside; pre-existing immobility (wheel chair or bed bound).

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

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

It started in 2018-12-06 with completion listed for 2020-11.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Complications (time frame: 90 days).

It also tracked 15 secondary outcomes, for example Grip Strength Scores, Inhalation Volume Measurements, 6 Minute Timed Walk Test Scores, Timed Get Up and Go Test Scores, Measurement of Muscle/ Fat Ratio and Incidence of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of NAD+ in 48 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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