The Memory and Cognitive Performance Study

A 28-day, Randomized, Double-Blind, Placebo Controlled Study of the Nutritional Supplement Braini for Support of Brain Health in Healthy Younger and Older Adults Based on Performance on Standard Memory and Cognitive Performance Assays

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Memory; Brain Health
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Braini

Detailed Description

The number of people affected by cognitive decline continues to rise as the US population ages. A recent report indicates that this decline can be seen as early as age 45. Optimizing cognitive function during adulthood is a key mechanism to combat cognitive decline as one reaches older adulthood.

Recent advances in cognitive wellness management have shown that tailored diet and lifestyle regimens that factor in various biomarkers and proclivities signaling cognitive decline (e.g. family genetics) can cause a person with a declining MOCA (measure of cognitive ability) score to restore or achieve an improved MOCA score.

A number of clinical trials have studied nutraceutical ingredients for improved memory enhancement and/or cognitive performance. While the individual ingredients are already well-utilized in commerce globally, the Braini® formulation is novel, harnessing synergistic effects seen in a new in vitro human neural cell challenge study carried out in South Korea by the study sponsor. In this study a series of independent in vitro (cell line) tests of the active nutraceutical constituents that comprise the Braini® dietary supplement product line were performed. The tests follow current peer-reviewed published methods for assessing the effects of biologically active compounds on human neuronal cells. The in vitro study showed a significant improvement in cell viability and reactive oxygen species (ROS) inhibition using the Braini® compounds.

Based on existing published science supporting the neuroprotective role of the Braini® formulation, this supplement may be useful and to improve cognitive function and health. Based on studies conducted outside the United States, the research team hypothesizes that orally ingested Braini® taken as directed (2 x 525 mg powdered capsules per day), will demonstrate superior improvements in standardized cognitive performance assays. MOCA scores will be used for screening patients. The research team aims to conduct a randomized, placebo-controlled, double-blinded dietary supplement study to evaluate this hypothesis among a cohort of younger and a cohort of older healthy adults.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Asheville, North Carolina, United States, 28804
      • University of North Carolina at Asheville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-30 or 55-80 years of age
2. Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
3. Willing to participate in the trial for 30-35 days, including taking a placebo
4. Able to understand and write English

Exclusion Criteria:

1. Clinically diagnosed with Alzheimer's disease, stroke, Parkinson's disease, or dementia
2. Taking prescription drugs to support memory/prevent cognitive decline in the past 180 days or to treat other diseases referenced below in criterion number.
3. Taking dietary supplements that include wild blueberry extract, Neurxcel, or silk portein peptide in the past 90 days
4. Active fibromyalgia, multiple sclerosis, seizures/epilepsy or other known diseases that affect memory or cognition
5. 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).
6. GI disorders known to impair absorption of nutrients
7. Traumatic brain injury (TBI) in personal history
8. MOCA test score <21
9. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Braini; 28-day oral capsules of Braini	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
Placebo Comparator: Placebo; 28-day oral capsule of placebo comparator	Dietary supplement: Placebo; Matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vita Naturel, LLC
• Collaborators: University of South Alabama; University of North Carolina at Asheville; Braini LLC
• Investigators: Principal Investigator: Amy J Lanou, PhD, UNC Asheville

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): April 9, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Executive Function; Brain Health; Cognitive Abilities; Mental Orientation; Short-term Memory
• Other Study ID Numbers: 1428244-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Upon starting the study, participants will be given an ID number, and the informed consent document will be separated from their file. Only study personnel will have access to both names and ID numbers. Data will be entered into a data management file (Excel and then SPSS) that will be kept on a password-protected computer. Data will be kept for three years and then destroyed (deleted and shredded).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No