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

NCT07076537 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-22

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Placebo

Placebo

DIETARY_SUPPLEMENT

Dietary Supplement with actives

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

Sponsors & Collaborators

  • Olly, PBC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-08-15
Completion
2025-09-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076537 on ClinicalTrials.gov