The Memory and Cognitive Performance Study

NCT04025255 | Completed

• 1 other identifier: 1428244-1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Brain Health; Cognitive Abilities; Mental Orientation; Short-term Memory; Executive Function

Outcome Measures

Primary Outcomes (1)

• CNS Vital Signs test battery

  The CNS Vital Signs test is a computerized neuropsychological battery that includes seven sub-tests designed to screen cognitive abilities. The Verbal Memory Test involves immediate and delayed recognition for words presented on the screen. The Visual Memory Test involves immediate and delayed recognition of geometric figures. The Finger Tapping Test involves rapidly press the space bar. The Symbol Digit Coding Test involves typing numbers that correspond to different symbols presented on screen. The Stroop Test contains three parts that involve responding to words and colors. The Shifting Attention Test involves matching geometric objects either by shape or by color. The Continuous Performance Test is a 5-min sustained attention test that involves responding to the target stimulus. Results are given as normed domain scores for Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility each with a mean score of 100 and SD of 15

  28 days

Study Arms (2)

Braini

EXPERIMENTAL

28-day oral capsules of Braini

Dietary Supplement: Braini

Placebo

PLACEBO COMPARATOR

28-day oral capsule of placebo comparator

Dietary Supplement: Placebo

Interventions

Braini DIETARY_SUPPLEMENT

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

Braini

Placebo DIETARY_SUPPLEMENT

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or 55-80 years of age
• Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
• Willing to participate in the trial for 30-35 days, including taking a placebo
• Able to understand and write English

You may not qualify if:

• Clinically diagnosed with Alzheimer's disease, stroke, Parkinson's disease, or dementia
• Taking prescription drugs to support memory/prevent cognitive decline in the past 180 days or to treat other diseases referenced below in criterion number.
• Taking dietary supplements that include wild blueberry extract, Neurxcel, or silk portein peptide in the past 90 days
• Active fibromyalgia, multiple sclerosis, seizures/epilepsy or other known diseases that affect memory or cognition
• Taking an medicines that are stimulants including Adderall XR (amphetamine), Concerta (methylphenidate), Dexedrine (amphetamine), Evekeo (amphetamine), Focalin XR (methylphenidate), Quillivant XR (methylphenidate), Ritalin (methylphenidate), Strattera (atomoxetine hydrochloride), or Vyvanse (lisdexamfetamine dimesylate).
• GI disorders known to impair absorption of nutrients
• Traumatic brain injury (TBI) in personal history
• MOCA test score \<21
• Pregnancy

Sponsors & Collaborators

• Vita Naturel, LLC: lead
• University of North Carolina at Asheville: collaborator
• Braini LLC: collaborator
• University of South Alabama: collaborator

Study Sites (1)

University of North Carolina at Asheville

Asheville, North Carolina, 28804, United States

Location

Related Publications (1)

• Lanou AJ, Mast AC, Hill BD, Kim SS, Hanaway P. A Randomized, Placebo-Controlled Clinical Trial of a Novel Dietary Supplement on Standardized CNS Vital Signs Cognitive Performance Parameters in Adults. J Integr Complement Med. 2023 May;29(5):303-312. doi: 10.1089/jicm.2022.0543. Epub 2023 Feb 28.

  PMID: 36856456 DERIVED

MeSH Terms

Conditions

Orientation, Spatial

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Amy J Lanou, PhD

  UNC Asheville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and study personnel will be blinded to group assignment. Study personnel will receive 24 bottles each of either "active" or "placebo" product from the supplier. The bottles would be numbered sequentially from 101 to 148 for the younger cohort and 201 to 248 for the older cohort. Within that sequence, randomized blocks of 4 bottles each would be filled with either "active" or "placebo" product, for a total of 12 blocks. The bottler will not reveal to anyone which bottles got filled with which type of product until after the conclusion of the trial. Except for having a different sequential number on the label, the bottles will be indistinguishable.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: October 1, 2019
• Primary Completion: April 9, 2020
• Study Completion: April 30, 2020
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)