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

Launched by OLLY, PBC · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical study is looking at whether a dietary supplement can help improve mood, reduce stress and anxiety, and support better sleep in children aged 5 to 14 who are generally healthy. The study will compare the effects of the supplement to a placebo, which is a harmless pill that doesn’t contain the active ingredient, to see if the supplement makes a real difference. To do this, children will complete simple questionnaires about their feelings, stress levels, and sleep habits at the start and end of the four-week study.

To take part, children need to be healthy, attend school, and be willing to follow the study’s schedule, including two visits to the clinic. Kids who have mental health conditions, take certain medications or supplements for mood or sleep, or have serious health problems won’t be eligible. Throughout the study, participants will take the supplement or placebo daily and fill out questionnaires about their mood and sleep. This study is not yet recruiting, but it aims to help understand if this supplement might be a safe and helpful option for supporting emotional well-being and sleep in children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willingness to actively participate in the study and to come to the scheduled visits.
• • 2. 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.
• • 3. Enrolled in and currently attending school at baseline and for the duration of the study period.
• • 4. 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.
• • 5. Ability to give consent (assent) for participation in the study
• Exclusion Criteria:
• • 1. Diagnosed with any mental health condition including chronic stress, GAD, impaired cerebral function, mood disorders, ADHD or similar conditions
• • 2. Currently taking any prescription medications or dietary supplements for sleep, anxiety, depression or ADHD
• • 3. Liver dysfunction
• • 4. Use of sleep aides including dietary supplements over the past 7 days
• • 5. History of reaction to the category of product tested
• • 6. Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• • 7. 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.
• • 8. 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.
• • 9. Subjects with a history of cancer within the past 5 years.
• • 10. Subjects with any planned surgeries and/or invasive medical procedures during the study.
• • 11. Individuals unable to communicate or cooperate with the principal investigator due to language
• • 12. Employees (and children of employees) of TKL and/or product brand owner or manufacturer.