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.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Nevada
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Las Vegas、Nevada、美国、89101
- Citruslabs
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Focus
大体时间: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
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Parent-Reported Focus
大体时间:Baseline, Week 2, Week 4, Week 6, and Week 8
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Assessed via parent-completed self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Parent-Reported Attention
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
|
合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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