CognitionNCT06837246
A Clinical Trial to Assess Cognitive Effects of Cognitive Nutritional Supplement in General Population
A study testing Cognitive Nutritional Supplement in people with Cognition and Concentration, run by Pharmavite LLC at 1 site in United States.
Trial summary
This is a double-blind, randomized, 12-week parallel study that aims to determine the effects of a cognitive nutritional supplement for 12 weeks on cognition parameters specific to attention/focus related domains, compared to a placebo control, in a general population of adult men and women in the United States. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Concentration, Attention
- What is being tested?
- Cognitive Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, ≥25 to ≤65 years of age at screening.
- English is the primary spoken language.
- Able to operate a study-provided iPad connected to the internet with a strong and reliable internet connection.
- Willing to consume 3 capsules per day for 12 weeks.
- Willing to review and follow all training materials provided.
- Willing to avoid alcohol, marijuana/hemp products (including CBD products), and vigorous physical activity 24 h prior to the baseline (week 0), mid-point (Week 6), and end of study (Week 12) cognition testing days.
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- Non-user or former user (cessation ≥12 months of screening) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco, nicotine gums or lozenges) with no plans to begin use during the study period.
- Willing to maintain habitual diet and physical activity patterns throughout the study.
- Willing to refrain from exclusionary medications, supplements, and products throughout the study.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator.
Who cannot join
- Cognition related criteria
- Diagnosed neurological disorder such as Alzheimer's disease, Parkinson's disease, stroke, intracranial hemorrhage, or any brain lesions including tumors.
- Diagnosed mental health disorder, such as major depressive disorder or any anxiety disorder. The use of daily or as-needed prescription medications to treat these conditions is also exclusionary.
- Any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies.
- Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
- Color blindness or visual impairments that cannot be corrected with glasses or contact lenses.
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- Diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift of overnight workers).
- History of repeated head injury (e.g., concussions from sports activities) or single trauma resulting in a period of unconsciousness lasting 1 h or more.
- Diagnosis of a learning and/or behavioral disorders such as dyslexia.
- Diagnosis of attention-deficit/hyperactivity disorder (ADHD).
- Use of any dietary supplements, other than a conventional once-daily multivitamin/mineral supplement that does not contain certain nutrient with cognitive effects, during the study period. Participants will be allowed to discontinue use of exclusionary dietary supplements during the screening period.
- Experienced a major life stress event, including the death of a loved one, marriage or divorce, birth of a child, unemployment, or moved to a new residence, within the last 6 months.
- General health related criteria
- History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- General safety related criteria
- Exposure to any non-registered drug product or has participated in another intervention study within 30 days prior to screening.
- Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½ oz. distilled spirits).
- Another household member is a current participant in this study.
- Any condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
- 6.2.1 Excluded Products
- Tobacco / nicotine products within 12 months of screening and throughout the study period
- Any non-registered drug product within 30 days of screening
- Alcohol within 24 h of each cognition test day
- Marijuana/hemp products (including CBD products) within 24 h of each cognition test day
- Current use of any medication used to treat mental health disorders, such as major depressive disorder or any anxiety disorder
- Current use of any medications used to treat ADHD
- Current use of any dietary supplements, other than a conventional once-daily multivitamin/mineral supplement that does not contain certain nutrient with cognitive effect. Participants will be allowed to discontinue use of exclusionary dietary supplements during the screening period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biofortis Innovation Services
Addison, Illinois, 60101
Elizabeth A Antoo, MD, 6306172000, elizabeth.antoo@mxns.com
About this study
Official title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess Cognitive Effects of Cognitive Nutritional Supplementation in the General Population
This is a double-blind, randomized, 12-week parallel study that aims to determine the effects of a cognitive nutritional supplement for 12 weeks on cognition parameters specific to attention/focus related domains, compared to a placebo control, in a general population of adult men and women in the United States.
- Conditions
- Cognition, Concentration, Attention, Focus
- Being tested
- Cognitive Nutritional Supplement, Placebo
- Keywords
- cognition, concentration, attention, problem-solving, capsule, clinical trial, placebo-controlled, focus, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Nutritional SupplementDietary supplement
Pills of cognitive nutritional supplement
PlaceboOther
Matching placebo to active
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Nutritional Supplement | Placebo comparator | Intervention is pills of cognitive nutrient Receives: Dietary Supplement: Cognitive Nutritional Supplement |
| Placebo | Active comparator | Intervention is pills of matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feature Match
Overall Score: The sum of the difficulties of all successfully answered problems, minus the sum of the difficulties of all incorrectly answered problems
Measured: Week 0, Week 6, and Week 12
Secondary outcomes (21)
Feature Match
Overall Reaction Time (ms): The average time taken to respond correctly
Total Number of Errors: Sum of incorrect responses
Measured: Week 0, Week 6, and Week 12
SART Test
Total Number of Errors: Sum of all commission errors (total count of inappropriate responses to a non-target stimulus [the number 3] and all omission errors (total number of times the participant failed to respond to a target stimulus [any number other than 3]
Measured: Week 0, Week 6, and Week 12
Double Trouble
Overall Score: The number of correctly answered problems, minus incorrect ones
Measured: Week 0, Week 6, and Week 12
Spatial Span
Overall Score (points): Total number of points scored during the task (points are awarded to each correctly solved puzzle, with more points awarded for more difficult puzzles)
Measured: Week 0, Week 6, and Week 12
Token Search
Average Score (number of boxes): Average number of boxes in which all tokens were located without error
Measured: Week 0, Week 6, and Week 12
Rotations
Overall Score: The sum of the difficulties of all successfully answered problems, minus the sum of the difficulties of all incorrectly answered problems
Measured: Week 0, Week 6, and Week 12
Number Ladder
Maximum Level Completed: The hardest level (i.e., the problem with the highest number of targets) that the individual successfully completed
Measured: Week 0, Week 6, and Week 12
Paired Associates
Maximum Level Completed: The hardest level (i.e., the problem with the highest number of targets) that the individual successfully completed
Measured: Week 0, Week 6, and Week 12
Odd One Out
Overall Score: The number of correctly answered problems, minus incorrect ones
Measured: Week 0, Week 6, and Week 12
Polygons
Overall Score: The sum of the difficulties of all successfully answered problems, minus the sum of the difficulties of all incorrectly answered problems
Measured: Week 0, Week 6, and Week 12
Grammatical Reasoning
Overall Score: The number of correctly answered problems, minus incorrect ones
Measured: Week 0, Week 6, and Week 12
Digit Span
Overall Score: The highest number completed
Measured: Week 0, Week 6, and Week 12
Spatial Spanning
Overall Score: (The minimum number of moves required to solve the puzzle * 2) - (the number of moves actually made)
Measured: Week 0, Week 6, and Week 12
THAT
Alertness rating (Sum of individual Likert scale scores)
Measured: Week 0, Week 6, and Week 12
Food Frequency Questionnaire: Total Kcal/Day
Healthy Eating Index (HEI)-2020: Total kcal/d
Measured: Week 0 and Week 12
Food Frequency Questionnaire: Total carbohydrate (g/d)
Healthy Eating Index (HEI)-2020: Total carbohydrate (g/d)
Measured: Week 0 and Week 12
Food Frequency Questionnaire: Total fiber (g/d)
Healthy Eating Index (HEI)-2020: Total fiber (g/d)
Measured: Week 0 and Week 12
Food Frequency Questionnaire: Total fat (g/d)
Healthy Eating Index (HEI)-2020: Total fat (g/d)
Measured: Week 0 and Week 12
Food Frequency Questionnaire: Total protein (g/d)
Healthy Eating Index (HEI)-2020: Total protein (g/d)
Measured: Week 0 and Week 12
Food Frequency Questionnaire: Total intake of other essential nutrient (mg/d)
Healthy Eating Index (HEI)-2020: Total intake of other certain essential nutrient (mg/day)
Measured: Week 0 and Week 12
Food Frequency Questionnaire: Total caffeine (mg/day)
Healthy Eating Index (HEI)-2020: Total caffeine (mg/day)
Measured: Week 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start24 Feb 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmavite LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Balchem Corporation, Biofortis Innovation Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837246
- Sponsor's protocol ID
- BIO-2409
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess Cognitive Effects of Cognitive Nutritional Supplementation in the General Population
- ClinicalTrials.gov ID
- NCT06837246
- Acronym / sponsor ID
- BIO-2409
- Conditions
- Cognition, Concentration, Attention, Focus
- Keywords
- cognition, concentration, attention, problem-solving, capsule, clinical trial, placebo-controlled, focus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- Pharmavite LLCIndustry (pharma, biotech, devices)
- Collaborators
- Balchem Corporation, Biofortis Innovation Services
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
This is a double-blind, randomized, 12-week parallel study that aims to determine the effects of a cognitive nutritional supplement for 12 weeks on cognition parameters specific to attention/focus related domains, compared to a placebo control, in a general population of adult men and women in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Nutritional Supplement | Placebo comparator | Dietary Supplement: Cognitive Nutritional SupplementIntervention is pills of cognitive nutrient |
| Placebo | Active comparator | Other: PlaceboIntervention is pills of matching placebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, ≥25 to ≤65 years of age at screening.
- English is the primary spoken language.
- Able to operate a study-provided iPad connected to the internet with a strong and reliable internet connection.
- Willing to consume 3 capsules per day for 12 weeks.
- Willing to review and follow all training materials provided.
Key exclusion criteria (28 listed)
- Cognition related criteria
- Diagnosed neurological disorder such as Alzheimer's disease, Parkinson's disease, stroke, intracranial hemorrhage, or any brain lesions including tumors.
- Diagnosed mental health disorder, such as major depressive disorder or any anxiety disorder. The use of daily or as-needed prescription medications to treat these conditions is also exclusionary.
- Any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies.
- Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
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 |
|---|---|---|
| Cognitive Nutritional SupplementPills of cognitive nutritional supplement | Dietary supplement | Cognitive Nutritional Supplement |
| PlaceboMatching placebo to active | Other | Placebo |
Primary outcome
Feature Match
Time frame: Week 0, Week 6, and Week 12
Overall Score: The sum of the difficulties of all successfully answered problems, minus the sum of the difficulties of all incorrectly answered problems
21 secondary outcomes
Feature Match
Time frame: Week 0, Week 6, and Week 12
SART Test
Time frame: Week 0, Week 6, and Week 12
Double Trouble
Time frame: Week 0, Week 6, and Week 12
Spatial Span
Time frame: Week 0, Week 6, and Week 12
Token Search
Time frame: Week 0, Week 6, and Week 12
Rotations
Time frame: Week 0, Week 6, and Week 12
Number Ladder
Time frame: Week 0, Week 6, and Week 12
Paired Associates
Time frame: Week 0, Week 6, and Week 12
Odd One Out
Time frame: Week 0, Week 6, and Week 12
Polygons
Time frame: Week 0, Week 6, and Week 12
Grammatical Reasoning
Time frame: Week 0, Week 6, and Week 12
Digit Span
Time frame: Week 0, Week 6, and Week 12
Spatial Spanning
Time frame: Week 0, Week 6, and Week 12
THAT
Time frame: Week 0, Week 6, and Week 12
Food Frequency Questionnaire: Total Kcal/Day
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total carbohydrate (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total fiber (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total fat (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total protein (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total intake of other essential nutrient (mg/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total caffeine (mg/day)
Time frame: Week 0 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Nutritional Supplement in people with Cognition and Concentration, run by Pharmavite 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 10 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 15 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth A Antoo, MD (6306172000, elizabeth.antoo@mxns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feature Match (time frame: Week 0, Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025.