Recruiting

Dietary Supplement

Sponsor:

Arizona State University

Code:

NCT07208279

Conditions

Aging

Healthy Aging

Cognition

Memory

Brain

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Axolt Brain Supplement

Bolero - Flavored Drink Placebo

Study Details

Brief summary:

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.

Conditions

Aging

Healthy Aging

Cognition

Memory

Brain

Study ID

NCT07208279

Start date

Sep 1, 2025

Status verified date

Oct, 2025

Completion date

Aug 11, 2026

Anticipated

Primary completion date

Aug 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Digit Span Forward [ Time Frame: From enrollment to the end of treatment at 45 days. ]
  • RAVLT Learning [ Time Frame: From enrollment to the end of treatment at 45 days. ]
  • Digit Span Backward [ Time Frame: From enrollment to the end of treatment at 45 days. ]
  • Symbol Digit Modalities Test (SDMT) [ Time Frame: From enrollment to the end of treatment at 45 days. ]
  • RAVLT Recall [ Time Frame: From enrollment to the end of treatment at 45 days. ]
  • Brain Fog Questionnaire [ Time Frame: From enrollment to the end of treatment at 45 days. ]
  • PHQ-9 [ Time Frame: From enrollment to the end of treatment at 45 days. ]
  • GAD-7 [ Time Frame: From enrollment to the end of treatment at 45 days. ]

Central Contacts and Locations

Central contacts

Judith Klein-Seetharaman, PhD

646-830-2622jkleinse@asu.edu

Locations

Community

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Kristina Wechsler, MS

516-404-1784kvanvori@asu.edu

More Information

Sponsor

Arizona State University

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arizona State University on 2025-10-28.