Actively Recruiting
Effects of Dietary Supplement Intervention on Cognitive Function and Psychological Well-Being in Adults Aged 55 and Older
Led by Arizona State University · Updated on 2025-10-28
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the oral liquid dietary supplement Axolt on cognitive function and psychological well-being in adults aged 55 and older who live independently and have no cognitive impairment. This pilot study compares Axolt to a control group using a flavored hydration drink, aiming to assess changes in cognition, mood, and well-being over 45 days. Validated, low-risk cognitive tests will be used to measure these changes. Participants are randomly assigned to one of two groups: the active group will consume one packet of Axolt dissolved in about 16 ounces of water daily for 45 days, while the control group will consume one packet of Bolero flavored drink mix in a similar manner for the same duration. The study plans to enroll 20 individuals, with 16 expected to complete the trial accounting for potential dropouts. During the study, participants will complete a 45-minute assessment at the start and end of the 45-day period. Researchers will measure cognitive function using tests such as Digit Span Forward and Backward, the Rey Auditory Verbal Learning Test, Symbol Digit Modalities Test, and surveys like the Brain Fog Questionnaire, PHQ-9, and GAD-7. The study will monitor adherence to daily supplement intake and psychological well-being throughout the trial, which is sponsored by Arizona State University.
CONDITIONS
Brief Title
Cognitive Vitality Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 years and older
- Live independently
- Self-report as healthy
- Adequate vision
- Fluent in English
- No history of mild cognitive impairment
- Not currently taking dietary supplements with the same active ingredients in Axolt or naturally flavored water
- Montreal Cognitive Assessment (MoCA) score of 24 or higher
- Able to provide written informed consent and medical clearance to participate
You will not qualify if you...
- Previous participation in a cognitive dietary supplement study in the last 12 months
- Montreal Cognitive Assessment (MoCA) score below 24
- History of seizures
- Epilepsy
- Parkinson's disease
- History of severe head trauma
- Uncontrolled hypertension
- Taking psychoactive medications
- Substance abuse
- Unwilling or unable to stop current dietary supplements with similar ingredients
- Planned surgery during the study period
- Use of medications known to interact with Axolt's active ingredients
- Minors and prisoners
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 - 45 days
Participants take either the Axolt Brain Supplement or the Bolero flavored drink placebo once daily for 45 days while cognitive function and psychological well-being are assessed.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Community
West Palm Beach, Florida, United States, 33401
Actively Recruiting
Research Team
J
Judith Klein-Seetharaman, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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