Cognitive FunctionNCT04025255
The Memory and Cognitive Performance Study
A study testing Braini in people with Cognitive Function and Memory, run by Vita Naturel, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Memory, Brain Health
- What is being tested?
- Braini
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-30 or 55-80 years of age
- Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
- Willing to participate in the trial for 30-35 days, including taking a placebo
- Able to understand and write English
Who cannot join
- Clinically diagnosed with Alzheimer's disease, stroke, Parkinson's disease, or dementia
- Taking prescription drugs to support memory/prevent cognitive decline in the past 180 days or to treat other diseases referenced below in criterion number.
- Taking dietary supplements that include wild blueberry extract, Neurxcel, or silk portein peptide in the past 90 days
- Active fibromyalgia, multiple sclerosis, seizures/epilepsy or other known diseases that affect memory or cognition
- 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).
- GI disorders known to impair absorption of nutrients
Show all 9Show fewer
- Traumatic brain injury (TBI) in personal history
- MOCA test score <21
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Asheville
Asheville, North Carolina, 28804
About this 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
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.
Read the 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
- Being tested
- Braini, Placebo
- Keywords
- Brain Health, Cognitive Abilities, Mental Orientation, Short-term Memory, Executive Function
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainiDietary 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
PlaceboDietary supplement
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Braini | Experimental | 28-day oral capsules of Braini Receives: Dietary Supplement: Braini |
| Placebo | Placebo comparator | 28-day oral capsule of placebo comparator Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Oct 2019
- Primary completion9 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vita Naturel, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina at Asheville, Braini LLC, University of South Alabama
- Responsible party
- Sponsor
- Investigators
- Amy J Lanou, PhD, Principal investigator, UNC Asheville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025255
- Sponsor's protocol ID
- 1428244-1
- Status last verified
- Nov 2022
- First submitted
- 16 Jul 2019
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Publications
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.
PubMed 36856456
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04025255
- Acronym / sponsor ID
- 1428244-1
- Conditions
- Cognitive Function, Memory, Brain Health
- Keywords
- Brain Health, Cognitive Abilities, Mental Orientation, Short-term Memory, Executive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vita Naturel, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina at Asheville, Braini LLC, University of South Alabama
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Braini | Experimental | Dietary Supplement: Braini28-day oral capsules of Braini |
| Placebo | Placebo comparator | Dietary Supplement: Placebo28-day oral capsule of placebo comparator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-30 or 55-80 years of age
- Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
- Willing to participate in the trial for 30-35 days, including taking a placebo
- Able to understand and write English
Key exclusion criteria (9 listed)
- Clinically diagnosed with Alzheimer's disease, stroke, Parkinson's disease, or dementia
- Taking prescription drugs to support memory/prevent cognitive decline in the past 180 days or to treat other diseases referenced below in criterion number.
- Taking dietary supplements that include wild blueberry extract, Neurxcel, or silk portein peptide in the past 90 days
- Active fibromyalgia, multiple sclerosis, seizures/epilepsy or other known diseases that affect memory or cognition
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainiA 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 | Dietary supplement | Braini |
| PlaceboMatched placebo | Dietary supplement | Placebo |
Primary outcome
CNS Vital Signs test battery
Time frame: 28 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Derived from this study: PubMed 36856456Lanou 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy J Lanou, PhD principal investigator
UNC Asheville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Braini in people with Cognitive Function and Memory, run by Vita Naturel, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS Vital Signs test battery (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.