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NOT YET RECRUITING
NCT07076537
NA

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

Sponsor: Olly, PBC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

5 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-07-15

Completion Date

2025-09-02

Last Updated

2025-07-22

Healthy Volunteers

Yes

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

Placebo

DIETARY_SUPPLEMENT

Dietary Supplement with actives

Dietary Supplement containing magnesium, L-theanine and lemon balm extract

Locations (1)

TKL Research

Fair Lawn, New Jersey, United States