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The Memory and Cognitive Performance Study

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ClinicalTrials.gov Identifier: NCT04025255
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
University of North Carolina, Asheville
Information provided by (Responsible Party):
Vita Naturel, LLC

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 to achieve the purpose of this study. The research team hypothesizes that Braini® will improve standardized performance scores on up to 7 different standard memory and cognitive performance assays more effectively than placebo.


Condition or disease Intervention/treatment Phase
Cognitive Function Memory Brain Health Dietary Supplement: Braini Dietary Supplement: Placebo Not Applicable

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 unique and 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 and related MOCA scores. The research team aims to conduct a randomized, placebo-controlled, double-blinded dietary supplement study to evaluate this hypothesis among a diverse sample of healthy young adults


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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. 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.
Primary Purpose: Other
Official Title: A 28-day, Randomized, Double-Blind, Placebo Controlled Study of the Nutritional Supplement Braini for Support of Brain Health in Healthy Young Adult Based on Performance on Standard Memory and Cognitive Performance Assays
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 19, 2019
Estimated Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Montreal Cognitive Assessment (MoCA) [ Time Frame: 28 days ]

    Montreal Cognitive Assessment is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

    The MoCA is a test of various types of cognitive abilities including orientation (e.g., state the date), short-term memory, executive function (e.g., draw a copy of a cube shape), language abilities (e.g., repeating two sentences correctly followed by listing all the words in the sentences that started with "f"), abstraction (e.g., explain how two things are alike), animal naming, attention (e.g., repeat a series of numbers forward), and clock-drawing (e.g., draw a clock that reads a specified time)



Secondary Outcome Measures :
  1. Cambridge Brain Sciences (CBS) Health Assessment [ Time Frame: 28 days ]
    The CBS Health Assessment is a 30-minute computer test assessing various aspects of cognitive functioning including visual/spatial working memory, episodic memory, spatial short-term memory, verbal reasoning, deductive reasoning, visual/spatial processing, planning and mental rotation. For all tests, after three mistakes, the task ends. Scores are normed for age and gender and results presented as percentiles for each of seven domains.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18-30 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 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 intended to support memory or cognitive function in the past 90 days
  4. Prior history of stroke, dementia, Parkinson's disease, 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 or >28
  9. Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025255


Contacts
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Contact: Amy J Lanou, PhD 828-250-2317 alanou@unca.edu
Contact: Aubri Rote, PhD 828-251-6044 arote@unca.edu

Locations
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United States, North Carolina
University of North Carolina at Asheville Recruiting
Asheville, North Carolina, United States, 28804
Contact: Amy J Lanou, PhD    828-250-2317    alanou@unca.edu   
Contact: Aubrey Mast, MPH    828-251-6513    acmast@unca.edu   
Sub-Investigator: Aubri Rote, PhD         
Sub-Investigator: Aubrey Mast, MPH         
Sponsors and Collaborators
Vita Naturel, LLC
University of North Carolina, Asheville
Investigators
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Principal Investigator: Amy J Lanou, PhD UNC Asheville

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Responsible Party: Vita Naturel, LLC
ClinicalTrials.gov Identifier: NCT04025255     History of Changes
Other Study ID Numbers: 1428244-1
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vita Naturel, LLC:
Brain Health
Cognitive Abilities
Mental Orientation
Short-term Memory
Executive Function