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

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.

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.