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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857956
• Other study ID #: 20290
• Status: Completed
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: April 11, 2023

Study information

• Verified date: May 2023
• Source: Proper Wild, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 11, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Anxiety
• Caffeine
• Mood

Intervention

Other:
• Proper Wild energy shot
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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Proper Wild, Inc.	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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