An Exploratory Investigation of a Supplement to Support Student Learning

Mental Fatigue Clinical Trial

Official title:

An Exploratory Investigation of a Supplement to Support Student Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528094
• Other study ID #: 20246
• Status: Completed
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2024
• Source: JoySpring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Concentration Ability Impaired
• Mental Fatigue

Intervention

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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
JoySpring	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of self-reported focus	Participants will respond to a survey to assess perceived changes in focus.	4 weeks
Primary	Examination of Self-reported concentration	Participants will respond to a survey to assess perceived changes in concentration	4 weeks
Primary	Examination of Self-reported mood states	Participants will respond to a survey to assess perceived changes in moods.	4 weeks