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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
16
https://axoltbrain.com/ Axolt is a brain health supplement. It includes native ingredients, formulated to help the brain perform at its best.
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.
Community
West Palm Beach, Florida, United States
RECRUITINGDigit Span Forward
Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 \*Higher score means better outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: From enrollment to the end of treatment at 45 days.