An Exploratory Investigation of a Supplement to Support Student Learning

Study Overview
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Brief Summary
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In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. The findings of this study will be used for marketing materials and to inform future trials using the supplement.

Official Title
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An Exploratory Investigation of a Supplement to Support Student Learning

Conditions
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Concentration Ability Impaired, Mental Fatigue

Intervention / Treatment
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* Dietary Supplement: GeniusDrops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form and a parental assent form Must be experiencing issues with focus, mood, and memory Must be looking to improve classroom performance Gets easily distracted Exclusion Criteria: Diagnosis of ADD or ADHD Currently taking a prescription medication meant to treat ADD or ADHD Diagnosed with additional conditions that would not allow them to adhere to the protocol. Willing to take a supplement targeting improving mood, concentration, and focus

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 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: GeniusDrops<br>Once participants have signed the consent and assent, they will take the baseline survey to gather information about their ability to focus and concentration. Once in the study, participants will be asked to take two dropperfuls of the test product (Genius Drops) twice daily. The participants can take the dropperful directly or add it to drinks/snacks. Participants will need to be in school during the entirety of the study. Participants will take a subsequent survey after two weeks in the trial and then another survey at the end of the trial. | Dietary Supplement: GeniusDrops<br>* The active ingredients listed below are safe and the study sponsor has noted there are no known side effects of the supplement. The main ingredients are: Hibiscus flower- Has been shown to boost oxygenation to the brain and vital organs. Has also demonstrated efficacy for boosting the immune system. Gingko leaf- Has been shown to stimulate memory by increasing mental sharpness and clarity. Rhodiola- Helps regulate energy and stress level. Gotu kola- Has been shown to have impacts on reducing anxiety. Licorice Root- Helps boost the key brain neurotransmitter called Brain Derived Neurotrophic factor which can help with cognitive development Peppermint Leaf- Reduces fatigue while helping improve cognitive abilities. Has also been shown to promote immune system function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination of self-reported focus | Participants will respond to a survey to assess perceived changes in focus. | 4 weeks | 
| Examination of Self-reported concentration | Participants will respond to a survey to assess perceived changes in concentration | 4 weeks | 
| Examination of Self-reported mood states | Participants will respond to a survey to assess perceived changes in moods. | 4 weeks |