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NCT07766642
A Clinical Trial to Evaluate the Effects of a Supplement on Children's Focus and Energy
Conditions: Difficulty Focusing, Poor Concentration, Poor Memory, Low Energy
Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Auri Nutrition
Location: Citruslabs Las Vegas Nevada
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07766642). StuddyBuddy aggregates publicly available trial information.