The Memory and Cognitive Performance Study

Vita Naturel

Status: Completed

Conditions: Cognitive Function; Brain Health; Memory

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Braini

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04025255

1428244-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

Braini

Experimental group

Description:

28-day oral capsules of Braini

Treatment:

Dietary Supplement: Braini

Placebo

Placebo Comparator group

Description:

28-day oral capsule of placebo comparator

Treatment:

Dietary Supplement: Placebo