Aging, Brain, Cognition, Healthy Aging, Memory
Conditions
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.
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_SUPPLEMENTAxolt 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_SUPPLEMENTBolero - 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.
Sponsors
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digit Span Forward | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 |
Countries
United States
Contacts
Primary ContactJudith Klein-Seetharaman, PhD
Outcome results
None listed