Cognitive Vitality Pilot Study

NCT ID: NCT07208279

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging Healthy Aging Cognition Memory Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Simple random convenience sampling procedures will be used to divide the sample (n = 16) into a control group and an active group (n = 8, respectively). The RAND function in Microsoft Excel will be used as a cost-effective tool to generate a random sample and numerical identification numbers will be assigned to each participant to protect personal information.

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. 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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Axolt Brain Supplement

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.

Group Type EXPERIMENTAL

Axolt Brain Supplement

Intervention Type DIETARY_SUPPLEMENT

https://axoltbrain.com/ Axolt is a brain health supplement. It includes native ingredients, formulated to help the brain perform at its best.

Bolero - Flavored Drink Placebo

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.

Group Type PLACEBO_COMPARATOR

Bolero - Flavored Drink Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Axolt Brain Supplement

https://axoltbrain.com/ Axolt is a brain health supplement. It includes native ingredients, formulated to help the brain perform at its best.

Intervention Type DIETARY_SUPPLEMENT

Bolero - Flavored Drink Placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Judith Klein-Seetharaman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Klein-Seetharaman, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Community

West Palm Beach, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Judith Klein-Seetharaman, PhD

Role: CONTACT

646-830-2622

Facility Contacts

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Kristina Wechsler, MS

Role: primary

516-404-1784

Other Identifiers

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STUDY00022585

Identifier Type: -

Identifier Source: org_study_id

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