NCT07076537

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Olly, PBC · Industry
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Placebo
DIETARY_SUPPLEMENT	Dietary Supplement with actives	Dietary Supplement containing magnesium, L-theanine and lemon balm extract

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-08-15
• Completion: 2025-09-02
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States