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Active Not Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07766642). StuddyBuddy aggregates publicly available trial information.