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NCT Number: NCT07208279

Cognitive Vitality Pilot Study

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.

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Key information

Conditions

Aging Brain Cognition Healthy Aging Memory

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community

West Palm Beach, Florida, 33401, United States

Location status: Recruiting

Location contact

Kristina Wechsler, MS

CONTACT

[email protected]

516-404-1784

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axolt Brain Supplement

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

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.

Primary outcomes

  1. Digit Span Forward

    Time frame: From enrollment to the end of treatment at 45 days.

    Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 *Higher score means better outcome

  2. RAVLT Learning

    Time frame: From enrollment to the end of treatment at 45 days.

    Rey Auditory Verbal Learning Test (RAVLT) Learning assesses short-term memory (10 min).

    Score: Min = 0, Max = 105 *Higher score means better outcome

  3. Digit Span Backward

    Time frame: From enrollment to the end of treatment at 45 days.

    Digit Span Backward measures working memory (5 min.). Score: Min = 2, Max = 8 *Higher score means better outcome

  4. Symbol Digit Modalities Test (SDMT)

    Time frame: From enrollment to the end of treatment at 45 days.

    Symbol Digit Modalities Test (SDMT) measures perceptual speed (5 min.). Score: Min = 0, Max = 120 *Higher score means better outcome

  5. RAVLT Recall

    Time frame: From enrollment to the end of treatment at 45 days.

    Rey Auditory Verbal Learning Test (RAVLT) Recall measures long-term memory (5 min.). Score: Min = 0, Max = 15 *Higher score means better outcome

  6. Brain Fog Questionnaire

    Time frame: From enrollment to the end of treatment at 45 days.

    Brain Fog Questionnaire allows entry of self-reported cognitive difficulties (5 min.). Score: Min = 0, Max = 10 *Lower score means better outcome

  7. PHQ-9

    Time frame: From enrollment to the end of treatment at 45 days.

    The Patient Health Questionnaire (PHQ-9) records depressive symptoms (5 min.). Score: Min = 0, Max = 27 *Lower score means better outcome

  8. GAD-7

    Time frame: From enrollment to the end of treatment at 45 days.

    Generalized Anxiety Disorder 7-item Questionnaire (GAD-7) quantifies anxiety (5 min.). Score: Min = 0, Max = 21 *Lower score means better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Judith Klein-Seetharaman, PhD

CONTACT

[email protected]

646-830-2622

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Effects of Dietary Supplement Intervention on Cognitive Function and Psychological Well-Being

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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