A Clinical Trial to Evaluate the Effects of a Supplement on Children's Focus and Energy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Focus
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female.
- •Be aged 4-
- •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.
排除标准
- •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.
研究组 & 干预措施
Auri Super Mushroom Daily Gummies For Kids
干预措施: Auri Super Mushroom Daily Gummies For Kids (Dietary Supplement)
结局指标
主要结局
Change in Focus
时间窗: 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
Change in Cognitive Performance
时间窗: 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
次要结局
- Change in Parent-Reported Focus(Baseline, Week 2, Week 4, Week 6, and Week 8)
- Change in Parent-Reported Attention(Baseline, Week 2, Week 4, Week 6, and Week 8)
- Change in Parent-Reported Sleep Quality(Baseline, Week 2, Week 4, Week 6, and Week 8)
- Change in Parent-Reported Gut Health(Baseline, Week 2, Week 4, Week 6, and Week 8)
- Change in Parent-Reported Natural Energy(Baseline, Week 2, Week 4, Week 6, and Week 8)
- Change in Parent-Reported Overall Well-Being(Baseline, Week 2, Week 4, Week 6, and Week 8)