A Randomized, Placebo-Controlled Clinical Trial of a Novel Dietary Supplement on Standardized CNS Vital Signs Cognitive Performance Parameters in Adults.

ABSTRACT

Objective: To test the effectiveness of a novel dietary supplement as a support for cognitive function in healthy younger and older adults Design: A double-blind, randomized, placebo-controlled trial of the dietary supplement, Braini® in two age cohorts with 60 participants: 31 healthy younger adults (18-30 years) and 29 healthy older adults (55-80 years). Intervention A 28-day intervention of a dietary supplement (active or placebo) taken daily with cognitive assessment using CNS Vital Signs computer-based testing at day 0 and 28. Participants were asked to fill out a daily survey regarding compliance with supplement protocol, changes in health, adherence to the protocol, and reported side effects. CNS Vital Signs provides aged normed aggregated outcome measures for Processing Speed, Psychomotor Speed, Reaction Time, Cognitive Flexibility, Executive Function, and Motor Speed. Results: Significant improvements in performance were found for two CNS Vital Signs domains, Cognitive Flexibility (p = 0.048), and Executive Function (p = 0.025) in the treated younger adults (n = 12) compared with the placebo group (n = 19) at day 28 compared with baseline. The Shifting Attention Test Reaction Time (SAT-RT), a measure of shifting attention correct response reaction time, showed significant improvement at 28 days in those taking Braini in both younger (p = 0.004) and older adult cohorts (p = 0.05) with an average improvement over the control subjects of 44%. No serious side effects were reported. Conclusions: The dietary formulation, Braini, safely and significantly improved cognitive flexibility and executive function in younger adults and trended positively in older adults in this study that was stopped prematurely due to pandemic restrictions. Scores on SAT-RT significantly improved in both younger and older adults. Further studies are needed to confirm that Braini reliably improves cognitive function in additional CNS domains in healthy adults. Clinical Trial Registration Clinicaltrials.gov under registration number NCT04025255.