An Exploratory Investigation of a Supplement to Promote Brain Health

Study Overview
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Brief Summary
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Providing a combination of synergistic dietary supplements, such as vitamins B6, B12, and folate, as well as curcumin, lemon balm, and American ginseng is hypothesized to promote brain health and aid with brain fog, mental clarity, ability to handle stress, mood, focus, and productivity, as well as promote overall well-being.

Official Title
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An Exploratory Investigation of a Supplement to Promote Brain Health

Conditions
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Memory Deficits, Cognitive Change, Stress

Intervention / Treatment
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* Dietary Supplement: The Daily Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.) Exclusion Criteria: Females who are pregnant or breastfeeding Anyone currently taking other supplements Anyone with a known allergic reaction Previous head trauma Anyone with chronic diseases such as diabetes, coronary heart disease, or cancer. Any psychological, mental, or neurodevelopmental disorders Consumes nicotine or marijuana in any form Previous or current alcohol addiction Consume more than 10 drinks per week

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Daily Supplement<br>Participants will use test product daily, and complete Biomarker assessments (at 1st dose, Day 7, Day 31), as well as surveys (at 1st dose, Day 7, Day 31), and Cognitive battery Assessments (at 1st dose, Day 7, Day 31). | Dietary Supplement: The Daily Supplement<br>* The ingredient list of the product includes the following: 400mg of curcumin (Longvida) 300mg of lemon balm extract (Cyracos) 200mg of American ginseng (Cereboost) 50mg of epigallocatechin gallate derived from green tea Organic oat milk powder Phosphatidylserine (SerinAid) (active) B6 (in the form of P5P) Folate (Quatrefolic) B12 Silica (non-active)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived changes in mental health symptoms as measured by Questionnaires | Questionnaires measure perceived changes in mental health symptoms (e.g., anxiety levels, mental clarity) and stress management on a scale of 0 (low levels of mental health symptoms) to 10 (very high levels of mental health symptoms) | 31 days | 
| Perceived changes in stress management as measured by Questionnaires | Questionnaires measure perceived changes in stress management on a scale of 0 (poor ability to manage stress) to 10 (excellent ability to manage stress) | 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cognitive Functioning | Cognitive battery questionnaires measure executive functioning, long term memory, working memory, and attention. | 31 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Focus, Memory, Attention, Stress