The Memory and Cognitive Performance Study

NCT ID: NCT04025255

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-04-30

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.

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.

Conditions

Cognitive Function; Memory; Brain Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Braini

28-day oral capsules of Braini

Group Type: EXPERIMENTAL

Braini

Intervention Type: 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

Placebo

28-day oral capsule of placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Matched placebo

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Matched placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina at Asheville

OTHER

Sponsor Role: collaborator

Braini LLC

INDUSTRY

Sponsor Role: collaborator

University of South Alabama

OTHER

Sponsor Role: collaborator

Vita Naturel, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy J Lanou, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Asheville

Locations

University of North Carolina at Asheville

Asheville, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36856456 (View on PubMed)

Other Identifiers

1428244-1

Identifier Type: -

Identifier Source: org_study_id