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

Not Applicable

Completed

• Conditions: Mood; Caffeine; ADHD; Attention Difficulties; Anxiety

• Registration Number: NCT05857956
• Lead Sponsor: Proper Wild, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-24
• Primary Completion: 2023-04-07
• Study Completion: 2023-04-11
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assess the product as a replacement for coffee or caffeinated beverages. [Time Frame: Baseline to Day 28]	28 days	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States