A Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Dietary Supplement with actives.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 5 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Placebo
Placebo - Dietary supplement Dietary Supplement with actives
Dietary Supplement containing magnesium, L-theanine and lemon balm extract
Primary outcome measures
- To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire. [Time frame: from enrollment to end of study at Week 4]
Secondary outcome measures (2)
- To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire. [Time frame: 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. [Time frame: from enrollment to end of study at Week 4]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- TKL Research — Fair Lawn
Identifiers
NCT: NCT07076537 · ULOLLYKC2