Actively Recruiting
A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess Cognitive Effects of Cognitive Nutritional Supplementation in the General Population
Led by Pharmavite LLC · Updated on 2025-04-15
422
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Pharmavite LLC
Lead Sponsor
B
Balchem Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a cognitive nutritional supplement on attention and focus in adults aged 25 to 65 years. This 12-week, double-blind, randomized study compares the supplement to a placebo in a general population of men and women in the United States, aiming to assess changes in cognitive functions related to attention and focus. Participants will take either pills of the cognitive nutritional supplement or matching placebo pills daily for 12 weeks. The study is conducted in a parallel design with two groups, where neither participants nor researchers know which treatment is given. Key assessments occur at the start, midpoint (week 6), and end (week 12) of the study. During the study, participants will use a study-provided iPad to complete various cognitive tests measuring attention and focus, including the Feature Match test and other related assessments at weeks 0, 6, and 12. Dietary intake and nutrient consumption are also monitored through food frequency questionnaires. Safety and adherence are tracked throughout the study period, with participants following specific guidelines on diet, physical activity, and substance use to ensure consistent testing conditions.
CONDITIONS
Brief 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 consume 3 capsules per day 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 of tobacco or nicotine products for at least 12 months prior to screening with no plans to start during the study
- Willing to maintain habitual diet and physical activity throughout the study
- Willing to avoid exclusionary medications, supplements, and products during the study
- Understands study procedures and provides informed consent
You will not qualify if you...
- Diagnosed neurological disorders such as Alzheimer's, Parkinson's, stroke, brain lesions, or tumors
- Diagnosed mental health disorders including major depression or anxiety, or use of medications for these conditions
- Infective or inflammatory brain diseases from viral, fungal, or syphilitic causes
- Planned elective hospitalizations during the study period
- Color blindness or visual impairments not correctable by glasses or contacts
- Diagnosed sleep disorders or jobs involving irregular overnight sleep hours
- History of repeated head injury or single trauma causing unconsciousness over 1 hour
- Diagnosed learning or behavioral disorders such as dyslexia
- Diagnosis of attention-deficit/hyperactivity disorder (ADHD)
- Use of dietary supplements (other than conventional once-daily multivitamins without cognitive nutrients) during the study unless discontinued during screening
- Major life stress events in the past 6 months such as death of a loved one, marriage/divorce, childbirth, unemployment, or moving
- History or presence of cancer in the last 2 years except non-melanoma skin cancer
- Female who is pregnant, planning pregnancy, lactating, or unwilling to use contraception during the study
- Exposure to non-registered drugs or participation in another intervention study within 30 days prior to screening
- Recent history (past 12 months) of alcohol or substance abuse
- Another household member currently participating in this study
- Any condition interfering with informed consent, protocol compliance, or study results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take either the cognitive nutritional supplement or a matching placebo daily for 12 weeks to assess cognitive effects.
3 visits at Week 0, Week 6, and Week 12
Trial Site Locations
Total: 1 location
1
Biofortis Innovation Services
Addison, Illinois, United States, 60101
Actively Recruiting
Research Team
E
Elizabeth A Antoo, MD
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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