AgingNCT07208279
Cognitive Vitality Pilot Study
A study testing Axolt Brain Supplement in people with Aging and Healthy Aging, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy Aging, Cognition
- What is being tested?
- Axolt Brain Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 11 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 55 years and older
- Live independently,
- Self-report as healthy
- Adequate vision
- Fluent in English
- No history of mild cognitive impairment
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Community
West Palm Beach, Florida, 33401
Kristina Wechsler, MS, 516-404-1784, kvanvori@asu.edu
About this study
Official title: Effects of Dietary Supplement Intervention on Cognitive Function and Psychological Well-Being
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.
Read the 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.
- Conditions
- Aging, Healthy Aging, Cognition, Memory, Brain
- Being tested
- Axolt Brain Supplement, Bolero - Flavored Drink Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axolt Brain SupplementDietary 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 PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Axolt Brain Supplement | Experimental | 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. Receives: Dietary Supplement: Axolt Brain Supplement |
| Bolero - Flavored Drink Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Bolero - Flavored Drink Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digit Span Forward
Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 *Higher score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
RAVLT Learning
Rey Auditory Verbal Learning Test (RAVLT) Learning assesses short-term memory (10 min).
Score: Min = 0, Max = 105 *Higher score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
Digit Span Backward
Digit Span Backward measures working memory (5 min.). Score: Min = 2, Max = 8 *Higher score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
Symbol Digit Modalities Test (SDMT)
Symbol Digit Modalities Test (SDMT) measures perceptual speed (5 min.). Score: Min = 0, Max = 120 *Higher score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
RAVLT Recall
Rey Auditory Verbal Learning Test (RAVLT) Recall measures long-term memory (5 min.). Score: Min = 0, Max = 15 *Higher score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
Brain Fog Questionnaire
Brain Fog Questionnaire allows entry of self-reported cognitive difficulties (5 min.). Score: Min = 0, Max = 10 *Lower score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
PHQ-9
The Patient Health Questionnaire (PHQ-9) records depressive symptoms (5 min.). Score: Min = 0, Max = 27 *Lower score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
GAD-7
Generalized Anxiety Disorder 7-item Questionnaire (GAD-7) quantifies anxiety (5 min.). Score: Min = 0, Max = 21 *Lower score means better outcome
Measured: From enrollment to the end of treatment at 45 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Sep 2025
- Primary completion11 Aug 2026 (estimated)
- Study completion11 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Klein-Seetharaman, Arizona State University
- Investigators
- Judith Klein-Seetharaman, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208279
- Sponsor's protocol ID
- STUDY00022585
- Status last verified
- Oct 2025
- First submitted
- 27 Sep 2025
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary outcomes will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Supplement Intervention on Cognitive Function and Psychological Well-Being
- ClinicalTrials.gov ID
- NCT07208279
- Acronym / sponsor ID
- STUDY00022585
- Conditions
- Aging, Healthy Aging, Cognition, Memory, Brain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 11 Aug 2026 (estimated)
- Study completion
- 11 Aug 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Axolt Brain Supplement | Experimental | Dietary Supplement: Axolt Brain SupplementThe 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. |
| Bolero - Flavored Drink Placebo | Placebo comparator | Dietary Supplement: Bolero - Flavored Drink PlaceboThe 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 55 years and older
- Live independently,
- Self-report as healthy
- Adequate vision
- Fluent in English
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axolt Brain Supplementhttps://axoltbrain.com/ Axolt is a brain health supplement. It includes native ingredients, formulated to help the brain perform at its best. | Dietary supplement | Axolt Brain Supplement |
| Bolero - Flavored Drink PlaceboThe 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. | Dietary supplement | Bolero - Flavored Drink Placebo |
Primary outcome
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: Yes. Primary outcomes will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Klein-Seetharaman, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axolt Brain Supplement in people with Aging and Healthy Aging, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Klein-Seetharaman, PhD (646-830-2622, jkleinse@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit Span Forward (time frame: From enrollment to the end of treatment at 45 days.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.