A Clinical Trial to Assess Cognitive Effects of Cognitive Nutritional Supplement in General Population

Last updated: April 10, 2025
Sponsor: Pharmavite LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Function

Treatment

Cognitive Nutritional Supplement

Placebo

Clinical Study ID

NCT06837246
BIO-2409
  • Ages 25-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, ≥25 to ≤65 years of age at screening.

  2. English is the primary spoken language.

  3. Able to operate a study-provided iPad connected to the internet with a strong andreliable internet connection.

  4. Willing to consume 3 capsules per day for 12 weeks.

  5. Willing to review and follow all training materials provided.

  6. Willing to avoid alcohol, marijuana/hemp products (including CBD products), andvigorous physical activity 24 h prior to the baseline (week 0), mid-point (Week 6),and end of study (Week 12) cognition testing days.

  7. Non-user or former user (cessation ≥12 months of screening) of tobacco or nicotineproducts (e.g., cigarette smoking, vaping, chewing tobacco, nicotine gums orlozenges) with no plans to begin use during the study period.

  8. Willing to maintain habitual diet and physical activity patterns throughout thestudy.

  9. Willing to refrain from exclusionary medications, supplements, and productsthroughout the study.

  10. Understands the study procedures and signs forms providing informed consent toparticipate in the study and authorizes the release of relevant protected healthinformation to the Principal Investigator.

Exclusion

Exclusion Criteria:

Cognition related criteria

  1. Diagnosed neurological disorder such as Alzheimer's disease, Parkinson's disease,stroke, intracranial hemorrhage, or any brain lesions including tumors.

  2. Diagnosed mental health disorder, such as major depressive disorder or any anxietydisorder. The use of daily or as-needed prescription medications to treat theseconditions is also exclusionary.

  3. Any infective or inflammatory brain disease, including those of viral, fungal, orsyphilitic etiologies.

  4. Elective hospitalizations planned (e.g., elective cosmetic procedures) during thestudy period.

  5. Color blindness or visual impairments that cannot be corrected with glasses orcontact lenses.

  6. Diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during theovernight hours is irregular (e.g., 3rd shift of overnight workers).

  7. History of repeated head injury (e.g., concussions from sports activities) or singletrauma resulting in a period of unconsciousness lasting 1 h or more.

  8. Diagnosis of a learning and/or behavioral disorders such as dyslexia.

  9. Diagnosis of attention-deficit/hyperactivity disorder (ADHD).

  10. Use of any dietary supplements, other than a conventional once-dailymultivitamin/mineral supplement that does not contain certain nutrient withcognitive effects, during the study period. Participants will be allowed todiscontinue use of exclusionary dietary supplements during the screening period.

  11. Experienced a major life stress event, including the death of a loved one, marriageor divorce, birth of a child, unemployment, or moved to a new residence, within thelast 6 months. General health related criteria

  12. History or presence of cancer in the prior two years, except for non-melanoma skincancer.

  13. 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 medicallyapproved form of contraception throughout the study period. General safety related criteria

  14. Exposure to any non-registered drug product or has participated in anotherintervention study within 30 days prior to screening.

  15. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcoholabuse is defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½oz. distilled spirits).

  16. Another household member is a current participant in this study.

  17. Any condition the Investigator believes would interfere with his ability to provideinformed consent, comply with the study protocol, or which might confound theinterpretation 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 studyperiod

  • 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 testday

  • Current use of any medication used to treat mental health disorders, such as majordepressive 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-dailymultivitamin/mineral supplement that does not contain certain nutrient withcognitive effect. Participants will be allowed to discontinue use of exclusionarydietary supplements during the screening period.

Study Design

Total Participants: 422
Treatment Group(s): 2
Primary Treatment: Cognitive Nutritional Supplement
Phase:
Study Start date:
February 24, 2025
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Biofortis Innovation Services

    Addison, Illinois 60101
    United States

    Active - Recruiting

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