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The Memory and Cognitive Performance Study

NCT04025255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-11-21

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the impact of a novel, neuro-protective and neuro-restorative dietary supplement (Braini®) on standardized memory and cognitive performance parameters. The principal active ingredients in the Braini® supplement have been commercially-available since at least 2015 or have achieved FDA new dietary ingredient notification (NDIN) in 2018, with no adverse events reported to the FDA.

A 28-day randomized, double-blinded, placebo-controlled dietary supplement study will be conducted with a cohort of younger and a cohort of colder adults to achieve the purpose of this study. The research team hypothesizes that Braini® will improve standardized performance scores measured by CNS Vital Signs standard memory and cognitive performance assays more effectively than placebo.

Conditions

  • Cognitive Function
  • Memory
  • Brain Health

Interventions

DIETARY_SUPPLEMENT

Braini

A novel, neuro-protective and neuro-restorative dietary supplement composed of a combination of active ingredients which have been commercially-available since at least 2015 or have achieved FDA new dietary ingredient notification (NDIN) status in 2018

DIETARY_SUPPLEMENT

Placebo

Matched placebo

Sponsors & Collaborators

  • University of North Carolina at Asheville

    collaborator OTHER

  • Braini LLC

    collaborator INDUSTRY

  • University of South Alabama

    collaborator OTHER

  • Vita Naturel, LLC

    lead INDUSTRY

Principal Investigators

  • Amy J Lanou, PhD · UNC Asheville

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-04-09
Completion
2020-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025255 on ClinicalTrials.gov