A Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.
研究概览
简要总结
The study will be a randomized, placebo control clinical study to assess the the efficacy for improvement of mood/stress and anxiety compared to placebo through validated survey questionnaire. The target population of this study is 5 to 14 years old. Participants will be asked to take questionnaires to collect baseline at the beginning of the study. The questionnaires are: Perceived Stress Scale for children (PSS-ch), The Positive Affect and Negative Affect Schedule-Child Form-children (PANAS-children) and the Children's Sleep Habits Questionnaire (CSHQ). The interventional treatment will be for a total of 4 weeks (28 days). Participants will be asked to take the questionnaires at the end of the 28 days. The subjects will attend two appointments in the clinic throughout the duration of the study.
详细描述
For these scale, here are some more details:
The PSS-C:
Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56.
Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.
The PANAS-C:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to actively participate in the study and to come to the scheduled visits.
- •Healthy (Healthy as determined by medical history as assessed by Qualified Investigator ) female and male subjects in good health between 5 to 14 years old.
- •Enrolled in and currently attending school at baseline and for the duration of the study period.
- •Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
- •Ability to give consent (assent) for participation in the study
排除标准
- •Diagnosed with any mental health condition including chronic stress, GAD, impaired cerebral function, mood disorders, ADHD or similar conditions
- •Currently taking any prescription medications or dietary supplements for sleep, anxiety, depression or ADHD
- •Liver dysfunction
- •Use of sleep aides including dietary supplements over the past 7 days
- •History of reaction to the category of product tested
- •Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
- •Participants having an acute or chronic disease or medical condition could put him/her at risk in the opinion of the Principal Investigator or compromise study outcomes.
- •Typical uncontrolled chronic or serious disease and/or conditions which would prevent participation in any clinical trials such as cancer, AIDs, diabetes, renal- impairment, mental illness, drug/alcohol addiction.
- •Subjects with a history of cancer within the past 5 years.
- •Subjects with any planned surgeries and/or invasive medical procedures during the study.
- •Individuals unable to communicate or cooperate with the principal investigator due to language
- •Employees (and children of employees) of TKL and/or product brand owner or manufacturer.
研究组 & 干预措施
Placebo
Oral dietary supplement. Instructions: Take 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m.
干预措施: Placebo (Dietary Supplement)
Dietary Supplement with actives
Oral dietary supplement. Instructions: Take 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m.
干预措施: Dietary Supplement with actives (Dietary Supplement)
结局指标
主要结局
To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.
时间窗: from enrollment to end of study at Week 4
PSS-children will be administered before the intervention to establish baseline, 40 min after taking the initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement in stress levels across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on the scales The PSS-C: (perceived stress scale -children form) Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56. Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.
次要结局
- To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire.(from enrollment to end of study at Week 4)
- To assess the efficacy for improvement of sleep quality compared to placebo through validated survey questionnaire.(from enrollment to end of study at Week 4)