- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07766642
A Clinical Trial to Evaluate the Effects of a Supplement on Children's Focus and Energy
This study will evaluate the effects of the Auri Super Mushroom Daily Gummies For Kids on focus and energy in children aged 4-12. The study is a single-arm, unblinded, virtual trial conducted over 8 weeks, in which all 35 enrolled participants will use the test product daily.
Parents of the participants will complete questionnaires at Baseline, Week 2, Week 4, Week 6, and Week 8 to assess perceived changes in their child's focus, attention, sleep quality, gut health, natural energy, and overall well-being. Participants will also undergo cognitive battery testing at Baseline, Week 4, and Week 8 to provide objective measurements of focus and cognitive performance.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89101
- Citruslabs
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be male or female.
- Be aged 4-12.
- Parent(s) reporting that their child has been experiencing issues regarding any of the following for the past four weeks: Difficulty focusing, Poor concentration, or Poor memory.
- Parent(s) who report that their child will be willing to complete cognitive assessments at regular intervals during the study.
- Any child who is generally healthy - does not live with any uncontrolled chronic disease.
- Parent(s) who are willing to follow the study protocol and support their child to complete all study actions.
- Any child who has no planned changes to school schedule, sleep routines, or behavioral therapies during the study duration.
- Anyone willing to refrain from introducing any new prescription medications, wellness products, supplements, or herbal remedies into their child's routine during the test period.
- If the child has been taking any other products, supplements, or herbal remedies, they have been taking these consistently for at least three months.
- Has had a stable diet and sleep schedule for at least four weeks prior to the study.
- Enrolled in and currently attending school at baseline and for the duration of the study period.
- Resides in the United States.
Exclusion Criteria:
- Any child with a neurodevelopmental condition or developmental delay, including autism spectrum disorder, intellectual disability, language disorder, uncontrolled anxiety or mood disorder, or dyslexia.
- Previous diagnosis of Attention-deficit hyperactivity disorder (ADHD).
- Any child currently undergoing any assessments for suspected neurodevelopmental conditions or developmental delay.
- Any child diagnosed with epilepsy or a seizure disorder.
- Any child diagnosed with a bleeding disorder.
- Any child with any known allergies or hypersensitivities to any supplement product ingredients.
- Any child with any chronic health conditions that could impact their participation in this study, such as cancer, mental health disorders, a history of serious illness in the last three months, or planned surgery during the study period.
- Any parent or child currently testing, or planning on starting in the next eight weeks, a product for another research study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Auri Super Mushroom Daily Gummies For Kids
|
All participants receive two Auri Super Mushroom Daily Gummies once daily in the morning with their first meal of the day for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Focus
Time Frame: Baseline, Week 4, and Week 8
|
Assessed via cognitive battery testing (Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, Spatial Planning) and self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
|
Change in Cognitive Performance
Time Frame: Baseline, Week 4, and Week 8
|
Assessed via cognitive battery testing (Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, Spatial Planning) and self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Parent-Reported Focus
Time Frame: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Assessed via parent-completed self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Parent-Reported Attention
Time Frame: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Assessed via parent-completed self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Parent-Reported Sleep Quality
Time Frame: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Assessed via parent-completed self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Parent-Reported Gut Health
Time Frame: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Assessed via parent-completed self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Parent-Reported Natural Energy
Time Frame: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Assessed via parent-completed self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Parent-Reported Overall Well-Being
Time Frame: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Assessed via parent-completed self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20827
- legacy-20827
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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