Cognitive Vitality Pilot Study

Arizona State University (ASU)

Status: Enrolling

Conditions: Aging; Cognition; Memory; Healthy Aging; Brain

Treatments: Dietary Supplement: Bolero - Flavored Drink Placebo; Dietary Supplement: Axolt Brain Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07208279

STUDY00022585

Details and patient eligibility

About

This study's purpose is to evaluate the effects of a dietary supplement on cognitive function and psychological well-being in community-dwelling older adults aged 55+. The study involves taking a commercially available dietary supplement daily for 45 days. A 45-minute assessment will be conducted at the beginning and again at the end of the study.

Full description

The primary aim of this randomized, single-site pilot study is to evaluate the effects of the oral liquid dietary supplement Axolt (https://axoltbrain.com) on cognitive function in adults aged 55 and older without cognitive impairment, compared to a control group taking a commercially available, hydration powdered drink flavoring, Bolero (https://bolerousa.net) daily for 45 days. The secondary aim is to assess changes in mood and psychological well-being with supplement intake. The study will use validated, low-risk cognitive measures at baseline and at the end of the study to measure change over time. 20 individuals age 55 years and older will be recruited. Sample size for enrollment: (n =8) for the active group and (n=8) in the control group (16 total), accounting for an anticipated 20% drop out rate.

Enrollment: 16 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups, including a placebo group

Axolt Brain Supplement

Experimental group

Description:

The active intervention group will be asked to consume 1 packet of Axolt dissolved in about 16 oz of water once a day for 45 days.

Treatment:

Dietary Supplement: Axolt Brain Supplement

Bolero - Flavored Drink Placebo

Placebo Comparator group

Description:

The control group will be asked to consume 1 packet of Bolero flavored water mix hydration enhancement also in about 16 oz of water once a day for 45 days.

Treatment:

Dietary Supplement: Bolero - Flavored Drink Placebo