In two randomized double-blinded, placebo-controlled clinical trials conducted in 2019-2020 at the University of North Carolina Asheville, one in healthy young adults and one in healthy seniors, subjects took either the Braini® supplement or placebo as directed for 28 days. Prof. Amy Lanou, PhD, executive director of The North Carolina Center of Health and Wellness at UNCA, was the Principal Investigator. Dr. Patrick Hanaway, MD, co-founder of the Institute for Functional Medicine at the Cleveland Clinic, was the observing clinical trial physician.
The UNCA trials assessed subjects’ overall cognitive performance at baseline prior to starting either Braini® or placebo, and then again at 28 days, using the CNS Vital Signs computerized neuro-cognitive performance self-testing suite. After the study concluded, results were assessed independently between the active Braini® and placebo cohorts in each age group by the pharmaceutical statistical analysis firm Pharma Initiatives (Chapel Hill, NC).
Outcomes Measured — Executive Function Stands Out
Of the CNS Vital Signs outcome measures scored for each subject, scores related to Executive Function stood out. According to CNS Vital Signs, Executive Function measures “how well a subject recognizes rules, categories, and manages or navigates rapid decision making.” It relates to one’s “ability to sequence tasks and manage multiple tasks simultaneously as well as tracking and responding to a set of instructions.”
Healthy Young Adults
In healthy young adults aged 18-30, subjects taking Braini® for 28 days experienced significant improvement vs placebo in Executive Function (p=.0215). The Braini® subjects improved by an average of 7.8% over the placebo subjects. Also, the researchers found that subjects taking Braini® experienced significantly improved CNS correct response shifting attention reaction time (SAT-RT) vs placebo by an average 1/10th of a second (p=.007). Researchers consider a p-value of less than .05 to be significant.
In a healthy high-functioning seniors group aged 55-80, taking Braini® for 28 days improved their shifting attention reaction time (SAT-RT) vs placebo and a p value of .05 was achieved, considered an indicative outcome meriting further study. The SAT-RT measure is a key component of the CNS Executive Function outcome score.