Effects of a dietary supplement on cognitive function
An Examination Into the Effects of a Nutraceutical Supplement on Cognition, Stress, and Eye and Skin Health in Adults With Self-reported Cognitive Complaints: a Randomised, Double-blind, Placebo-controlled Trial
NA · Pharmanex · NCT05941949
This study is testing whether a dietary supplement made from grape juice extract, astaxanthin, and vitamin E can help healthy people with memory or attention problems think better over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Pharmanex (industry) |
| Locations | 1 site (Duncraig, Western Austrailia) |
| Trial ID | NCT05941949 on ClinicalTrials.gov |
What this trial studies
This prospective, placebo-controlled, double-blinded study investigates the impact of a dietary supplement containing grape juice extract, astaxanthin, and vitamin E on cognitive performance over a 12-week period. Participants will be assessed on cognitive performance and self-reported outcomes through questionnaires, alongside evaluations of general well-being, mood, oxidative stress markers, neurogenesis, and overall safety. The study aims to determine both the efficacy and safety of the supplement in healthy individuals experiencing memory or attention issues.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-65 who report mild memory or attention problems and meet specific health criteria.
Not a fit: Patients with diagnosed dementia or significant unmanaged medical conditions are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function and overall well-being in individuals with mild memory or attention concerns.
How similar studies have performed: Other studies have shown promising results with similar dietary supplements, suggesting potential efficacy in improving cognitive function.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Health Individuals * Residing in independent living accommodations * Subjective report of memory or attention problems by answering 'yes' to the following questions: Do you have problems with your memory, attention, or concentration? * Non-smoker * Body Mass Index (BMI) between 18-35 kg/m2 * No plan to commence new treatments over the study period * Understand, willing and able to comply with all study procedures * Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the study Exclusion Criteria: * Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer's Association (NIA/AA) criteria * A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M) * Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/malignancy * Diagnosis of a psychiatric disease (other than mild-to moderate depression of anxiety) and/or neurological condition/disease (e.g. Parkinson's, Alzheimer's disease) * History of paralysis, stroke or seizures or head injury (with loss of consciousness) * Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibiters, or steroid medications. * Taking vitamins or herbal supplements that are reasonably expected to influence study measures * In the last 6 month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcome * Alcohol intake greater than 14 standard drinks per week * Current or 12-month history of illicit drug abuse * Pregnant women, women who are Brest feeding, or women who intend to fall pregnant * Any significant surgeries over the last year * Planned major lifestyle change in the next 3 months
Where this trial is running
Duncraig, Western Austrailia
- Clinical Research Australia — Duncraig, Western Austrailia, Australia (RECRUITING)
Study contacts
- Principal investigator: Adrian Lopresti, MD — Clinical Research Australia
- Study coordinator: Adrian Lopresti, MD
- Email: adrian@clinicalresearch.com.au
- Phone: 61-8-9448-7376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dietary Supplement, Cognition, Healthy, Memory, Mental Stress, Wellbeing, Antioxidant, Astaxanthin