A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms

Study Overview
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Brief Summary
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This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28. Attention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus, and attention, will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.

Official Title
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A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms

Conditions
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ADHD, Attention Difficulties, Mood, Anxiety, Caffeine

Intervention / Treatment
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* Other: Proper Wild energy shot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently experiencing symptoms associated with ADHD, including: Impulsiveness. Disorganization and problems prioritizing Poor time management skills Problems focusing on a task Trouble multitasking Excessive activity or restlessness Poor planning Age 18-55 Self-reported issues with focus and/or productivity Generally healthy - don't live with any uncontrolled chronic disease Exclusion Criteria: Currently taking prescription medication for ADHD Currently supplementing with L-Theanine. Known to respond negatively to caffeine (no effect, makes them sleepy or feel unwell) People with a high caffeine tolerance defined as regular consumption of >400mg of caffeine (>4 coffees) per day. Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. Anyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant Unwilling to follow the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Proper Wild energy shot<br>Participants will take one bottle daily of Proper Wild Energy shot in the morning. Participants will be advised to drink one bottle in the morning, with or without a meal, depending on their preference, as a replacement for their usual first caffeinated beverage of the day. | Other: Proper Wild energy shot<br>* 100% plant-based energy shot containing natural caffeine, L-Theanine, purified water, pineapple juice concentrate, natural flavors, kiwi juice concentrate, organic lemon juice concentrate, organic strawberry juice concentrate, monk fruit juice concentrate, pink himalayan sea salt.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28] | Survey-based assessment (0-5) scale of changes in symptoms associated with ADHD. Parameters explored include focus & concentration, productivity, mood, and brain fog. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the product as a replacement for coffee or caffeinated beverages. [Time Frame: Baseline to Day 28] | Survey-based assessment regarding changes in daily coffee/beverage consumption, stress, anxiety, jitters, energy crash, and gastrointestinal upset. Responses will be statistically analyzed and reported as % of subject responses. | 28 days |