A Clinical Trial to Evaluate the Effects of a Supplement on Cognitive Performance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Change in Cognitive Battery Test Score (Polygons)
Study Overview
Brief Summary
This study evaluates the effects of the Xula Herbs Mind Food supplement on cognitive performance in adults aged 25-70 who report difficulty concentrating, memory challenges, brain fog, and low productivity. The trial is a single-arm, open-label, virtual study conducted over 6 weeks in 35 participants.
Participants will use the test product three times daily (sprayed three times under the tongue, at least 30 minutes before a meal, and not after 6 pm) for the duration of the study. Cognitive performance will be assessed via a Cognitive Battery Test at Baseline and Week 6, and self-reported questionnaires will be completed at Baseline, Week 2, Week 4, and Week 6.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be male or female.
- •Be aged 25-
- •Anyone experiencing issues with all of the following over the past four weeks: difficulty concentrating or low mental sharpness
- •difficulty with memory
- •experiences of brain fog or lack of mental clarity
- •feeling of low productivity.
- •Willing to refrain from taking any new products, over-the-counter medications, or supplements that may affect cognitive ability during the test period.
- •If taking any products, over-the-counter medications, or supplements that may affect cognitive ability, has been doing so consistently for at least three months and is willing to maintain this routine for the duration of the study.
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
Exclusion Criteria
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Anyone with any allergies or sensitivities to any of the study product ingredients.
- •Anyone who is pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- •Anyone unwilling to follow the study protocol.
- •Anyone diagnosed with a neurodegenerative condition.
- •Anyone taking an anticoagulant (also commonly referred to as a blood thinner) prescription medication.
- •Anyone with liver disease or kidney disease.
- •Anyone taking hormonal birth control or contraceptives.
- •Anyone with a history of substance abuse.
- •Anyone who drinks heavily (8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- •Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
Outcomes
Primary Outcomes
Change in Cognitive Battery Test Score (Polygons)
Time Frame: Baseline and Week 6
Change in performance on the Polygons timed processing test, measuring the brain's ability to sort and clarify information and judge the correct response, assessed via the Cognitive Battery Test
Change in Cognitive Battery Test Score (Double Trouble)
Time Frame: Baseline and Week 6
Change in performance on the Double Trouble timed test, measuring selective attention and processing speed based on the Stroop paradigm, assessed via the Cognitive Battery Test
Change in Cognitive Battery Test Score (Feature Match)
Time Frame: Baseline and Week 6
Change in performance on the Feature Match timed focus and processing task, assessed via the Cognitive Battery Test
Change in Cognitive Battery Test Score (Paired Associates)
Time Frame: Baseline and Week 6
Change in performance on the Paired Associates memory task, measuring recall of sequences and locations of items in increasing quantity, assessed via the Cognitive Battery Test
Change in Cognitive Battery Test Score (Digit Span)
Time Frame: Baseline and Week 6
Change in performance on the Digit Span task, measuring short-term memory and attention by recalling displayed number sequences of increasing length, assessed via the Cognitive Battery Test
Change in Cognitive Battery Test Score (Spatial Planning)
Time Frame: Baseline and Week 6
Change in performance on the Spatial Planning timed task, measuring executive function and ability to reorganize numbers into correct order, assessed via the Cognitive Battery Test
Secondary Outcomes
- Change in Self-Reported Mental Clarity(Baseline, Week 2, Week 4, and Week 6)
- Change in Self-Reported Focus(Baseline, Week 2, Week 4, and Week 6)
- Change in Self-Reported Memory Function(Baseline, Week 2, Week 4, and Week 6)
- Change in Self-Reported Alertness(Baseline, Week 2, Week 4, and Week 6)
- Change in Self-Reported Mood(Baseline, Week 2, Week 4, and Week 6)
- Change in Self-Reported Brain Fog(Baseline, Week 2, Week 4, and Week 6)