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Recruiting NCT07208279

Cognitive Vitality Pilot Study

No phase Interventional Aging Healthy Aging Cognition Memory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Axolt Brain Supplement, Bolero - Flavored Drink Placebo.
Who it may be relevant to
Registry conditions: Aging, Healthy Aging, Cognition, Memory. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Dietary supplement 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.
  • 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.

Primary outcome measures

  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Community — West Palm Beach

Identifiers

NCT: NCT07208279 · STUDY00022585

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗