Clinical trial NCT04025255: The Memory and Cognitive Performance Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Memory
Brain Health
Keywords: Brain Health
Cognitive Abilities
Mental Orientation
Short-term Memory
Executive Function
Lead sponsor: Vita Naturel, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina at Asheville
name: Braini LLC
name: University of South Alabama
First posted: 2019-07-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: CNS Vital Signs test battery
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Asheville
country: United States
facility: University of North Carolina at Asheville
state: North Carolina
Study officials:
affiliation: UNC Asheville
name: Amy J Lanou, PhD
role: PRINCIPAL_INVESTIGATOR
References: