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NCT04025255

The Memory and Cognitive Performance Study

Completed NA Last updated 21 November 2022
What this trial tests

NA trial testing Braini in Cognitive Function in 74 participants. Completed in 30 April 2020.

Timeline
1 October 2019
Primary endpoint
9 April 2020
30 April 2020

Quick facts

Lead sponsorVita Naturel, LLC
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment74
Start date1 October 2019
Primary completion9 April 2020
Estimated completion30 April 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vita Naturel, LLC

Who can join

Adults 18 to 80, any sex, with Cognitive Function or Memory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Randomized, Placebo-Controlled Clinical Trial of a Novel Dietary Supplement on Standardized CNS Vital Signs Cognitive Performance Parameters in Adults.
    Lanou AJ, Mast AC, Hill BD, Kim SS, et al · · 2023 · cited 2× · PMID 36856456 · DOI 10.1089/jicm.2022.0543

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Other recruiting trials for Cognitive Function

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing