A Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population

Официальное название

A Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population

Обзор

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.

Подробное описание

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:

Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in:

* Positive Affect (PA): 15 to 75 * Negative Affect (NA): 15 to 75

Interpretation:

Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)

The CSHQ Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99.

Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.

Вмешательства

• Пищевая добавка Placebo
  Placebo
• Пищевая добавка Dietary Supplement with actives
  Dietary Supplement containing magnesium, L-theanine and lemon balm extract

Первичные конечные точки

• To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire. [Срок оценки: from enrollment to end of study at Week 4]

Вторичные конечные точки (2)

• To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire. [Срок оценки: 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. [Срок оценки: from enrollment to end of study at Week 4]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• TKL Research — Fair Lawn

Идентификаторы

NCT: NCT07076537 · ULOLLYKC2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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