An Exploratory Investigation of a Supplement to Support Student Learning

In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. The findings of this study will be used for marketing materials and to inform future trials using the supplement.

Study Overview

• Status: Completed
• Conditions: Mental Fatigue; Concentration Ability Impaired
• Intervention / Treatment: Dietary supplement: GeniusDrops

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form and a parental assent form
• Must be experiencing issues with focus, mood, and memory
• Must be looking to improve classroom performance
• Gets easily distracted

Exclusion Criteria:

• Diagnosis of ADD or ADHD
• Currently taking a prescription medication meant to treat ADD or ADHD
• Diagnosed with additional conditions that would not allow them to adhere to the protocol.
• Willing to take a supplement targeting improving mood, concentration, and focus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GeniusDrops; Once participants have signed the consent and assent, they will take the baseline survey to gather information about their ability to focus and concentration. Once in the study, participants will be asked to take two dropperfuls of the test product (Genius Drops) twice daily. The participants can take the dropperful directly or add it to drinks/snacks. Participants will need to be in school during the entirety of the study. Participants will take a subsequent survey after two weeks in the trial and then another survey at the end of the trial.

Dietary supplement: GeniusDrops; The active ingredients listed below are safe and the study sponsor has noted there are no known side effects of the supplement. The main ingredients are: Hibiscus flower- Has been shown to boost oxygenation to the brain and vital organs. Has also demonstrated efficacy for boosting the immune system. Gingko leaf- Has been shown to stimulate memory by increasing mental sharpness and clarity. Rhodiola- Helps regulate energy and stress level. Gotu kola- Has been shown to have impacts on reducing anxiety. Licorice Root- Helps boost the key brain neurotransmitter called Brain Derived Neurotrophic factor which can help with cognitive development Peppermint Leaf- Reduces fatigue while helping improve cognitive abilities. Has also been shown to promote immune system function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination of self-reported focus	Participants will respond to a survey to assess perceived changes in focus.	4 weeks
Examination of Self-reported concentration	Participants will respond to a survey to assess perceived changes in concentration	4 weeks
Examination of Self-reported mood states	Participants will respond to a survey to assess perceived changes in moods.	4 weeks

Collaborators and Investigators

• Sponsor: JoySpring
• Collaborators: Citruslabs
• Investigators: Principal Investigator: Christopher Hill, Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue
• Other Study ID Numbers: 20246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No