Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Digit Span Forward | Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 *Higher score means better outcome | 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 | 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 | 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 | 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 | 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 | From enrollment to the end of treatment at 45 days. |
| PHQ-9 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith Klein-Seetharaman, PhD | Contact | 646-830-2622 | jkleinse@asu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Judith Klein-Seetharaman, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community | Recruiting | West Palm Beach | Florida | 33401 | United States |
Primary outcomes will be shared.
Data will be made available after all data have been collected, entered into the REDCap database, data cleaning procedures have been completed, and the primary articles have been published. Data will be available on or before 1/1/2028 and will remain available for a minimum of 3 years.
The Arizona State University Research Data Repository can be accessed freely by investigators. This data repository has supporting information about the protocol and contact information for the investigative team.
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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. |
|
The Patient Health Questionnaire (PHQ-9) records depressive symptoms (5 min.). Score: Min = 0, Max = 27 *Lower score means better outcome |
| 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 | From enrollment to the end of treatment at 45 days. |