Cognitive Vitality Pilot: 45-day supplement for thinking and mood
Effects of Dietary Supplement Intervention on Cognitive Function and Psychological Well-Being
This study will test whether taking the liquid supplement Axolt daily for 45 days helps thinking and mood in healthy adults aged 55 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (West Palm Beach, Florida) |
| Trial ID | NCT07208279 on ClinicalTrials.gov |
What this trial studies
This is a randomized, single-site pilot comparing the oral liquid supplement Axolt to a flavored powdered drink placebo (Bolero) taken daily for 45 days. Healthy, community-dwelling adults aged 55+ with a MoCA score of 24 or higher will be enrolled and randomized to active or control groups. Validated, low-risk cognitive and mood measures will be administered in a 45-minute assessment at baseline and again at the end of the 45-day period. The planned sample is small (about 16 completers, with enrollment targeted at 20 to allow for dropout) and is intended to generate preliminary data for larger trials.
Who should consider this trial
Good fit: Independent, English-speaking adults aged 55 or older who self-report as healthy, have adequate vision, a MoCA score ≥24, are not taking similar supplements, and can provide consent and medical clearance are ideal candidates.
Not a fit: People with cognitive impairment, neurological disorders (e.g., epilepsy, Parkinson's), uncontrolled hypertension, recent severe head trauma, substance abuse, or those on psychoactive medications or similar supplements are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the supplement could modestly improve memory or psychological well-being in healthy older adults and justify larger clinical testing.
How similar studies have performed: Previous dietary supplement trials for cognition have shown mixed and often small effects, and this specific Axolt formulation does not appear to have published randomized trial results to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 55 years and older * Live independently, * Self-report as healthy * Adequate vision * Fluent in English * No history of mild cognitive impairment * Currently not taking dietary supplements with the same active ingredients in Axolt or naturally flavored water * A Montreal Cognitive Assessment \[12\] (MOCA) score ≥ 24 * Able to provide written informed consent, and medical clearance to participate. Exclusion Criteria: * Previous participation in a cognitive dietary supplement study in the last 12 months * A score of \< 24 on the Montreal Cognitive Assessment (MoCA) as a potential risk for obtaining informed consent * History of seizures * Epilepsy * Parkinson's disease * History of severe head trauma * Uncontrolled hypertension * On psychoactive medications * Substance abuse * Unwilling or unable to discontinue current dietary supplements with similar ingredients * Planned surgery during the study period * Medications known to interact with active ingredients with Axolt * Minors and prisoners will be excluded.
Where this trial is running
West Palm Beach, Florida
- Community — West Palm Beach, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Judith Klein-Seetharaman, PhD — Arizona State University
- Study coordinator: Judith Klein-Seetharaman, PhD
- Email: jkleinse@asu.edu
- Phone: 646-830-2622
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.