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

Sponsor

Proper Wild, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05857956

Collaborator

Citruslabs (Industry)

Enrollment

Location

Arm

1.5

Actual Duration (Months)

26.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD Attention Difficulties Mood Anxiety Caffeine	Other: Proper Wild energy shot	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 24, 2023

Actual Primary Completion Date :

Apr 7, 2023

Actual Study Completion Date :

Apr 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proper Wild energy shot 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 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.

Arm

Intervention/Treatment

Experimental: Proper Wild energy shot

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

Proper Wild, Inc.
Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Proper Wild, Inc.

ClinicalTrials.gov Identifier:

NCT05857956

Other Study ID Numbers:

20290

First Posted:

May 15, 2023

Last Update Posted:

May 15, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 15, 2023