Actively Recruiting
A Clinical Trial to Assess Cognitive Effects of Cognitive Nutritional Supplement in General Population
Led by Pharmavite LLC · Updated on 2025-04-15
422
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
P
Pharmavite LLC
Lead Sponsor
B
Balchem Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial to Assess Cognitive Effects of Cognitive Nutritional Supplement in General Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 25 to 65 years at screening
- English is the primary spoken language
- Able to operate a study-provided iPad with a strong and reliable internet connection
- Willing to take 3 capsules daily for 12 weeks
- Willing to review and follow all training materials provided
- Willing to avoid alcohol, marijuana/hemp products, and vigorous physical activity 24 hours before cognition testing days at baseline, week 6, and week 12
- Non-user or former user (stopped at least 12 months before screening) of tobacco or nicotine products with no plans to start during the study
- Willing to maintain usual diet and physical activity throughout the study
- Willing to avoid exclusionary medications, supplements, and products during the study
- Understands the study procedures and provides informed consent
You will not qualify if you...
- Diagnosed neurological disorders like Alzheimer's disease, Parkinson's disease, stroke, brain hemorrhage, or brain tumors
- Diagnosed mental health disorders such as major depressive disorder or anxiety, or use of related prescription medications
- Infective or inflammatory brain diseases including viral, fungal, or syphilitic causes
- Planned elective hospitalizations during the study
- Color blindness or visual impairments not correctable with glasses or contacts
- Diagnosed sleep disorders or work schedules with irregular overnight sleep
- History of repeated head injuries or a single head trauma causing unconsciousness for 1 hour or more
- Diagnosed learning or behavioral disorders such as dyslexia
- Diagnosis of attention-deficit/hyperactivity disorder (ADHD)
- Use of dietary supplements other than a conventional once-daily multivitamin without cognitive effect nutrients during the study
- Experienced major life stress events in the past 6 months
- History or presence of cancer in the past 2 years, except non-melanoma skin cancer
- Pregnancy, planning pregnancy, lactation, or unwillingness to use approved contraception during the study
- Exposure to non-registered drug products or participation in another intervention study within 30 days before screening
- Recent history (within 12 months) of alcohol or substance abuse
- Another household member currently participating in the study
- Any condition that could interfere with informed consent, study compliance, or interpretation of results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Biofortis Innovation Services
Addison, Illinois, United States, 60101
Actively Recruiting
Research Team
E
Elizabeth A Antoo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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