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

NCT05857956 | Completed

• 1 other identifier: 20290
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Attention Difficulties; Mood; Anxiety; Caffeine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  28 days

Study Arms (1)

Proper Wild energy shot

EXPERIMENTAL

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

Interventions

Proper Wild energy shot OTHER

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.

Proper Wild energy shot

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Proper Wild, Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: February 24, 2023
• Primary Completion: April 7, 2023
• Study Completion: April 11, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

US (1)