An Exploratory Investigation of a Supplement to Support Student Learning

NCT05528094 | Completed

• 1 other identifier: 20246
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concentration Ability Impaired; Mental Fatigue

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

GeniusDrops

EXPERIMENTAL

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

Interventions

GeniusDrops DIETARY_SUPPLEMENT

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.

GeniusDrops

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JoySpring: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Christopher Hill

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: April 14, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

US (1)