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Dietary Supplement for Stress, Anxiety, Mood, and Sleep in Children

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What is being tested

Placebo

+ Dietary Supplement with actives

Dietary Supplement
Who is being recruted

From 5 to 14 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorOlly, PBC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on exploring the effects of a dietary supplement on stress, anxiety, mood, and sleep in children. The aim is to see if this supplement can help improve these aspects of mental and emotional well-being, which are important for healthy development and daily functioning. By addressing these issues in a pediatric population, the study seeks to find new ways to support children who might struggle with stress and sleep problems, potentially offering an alternative to more conventional treatments. Participants in the study will consume the dietary supplement, and researchers will assess its impact by using various scoring systems. These include the Perceived Stress Scale for Children (PSS-C), which measures stress levels, the Positive and Negative Affect Schedule for Children (PANAS-C) that assesses mood, and the Children's Sleep Habits Questionnaire (CSHQ) to evaluate sleep patterns. Each of these tools helps determine if the supplement has a positive or negative effect by looking at changes in scores, where higher scores typically indicate more stress, negative emotions, or disturbed sleep. The study is designed to be interventional, meaning it actively involves participants taking the supplement and observing changes.

Official TitleA Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
NCT07076537
Principal SponsorOlly, PBC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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.

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12 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Oral dietary supplement. Instructions: Take 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m.

Group II

Active Comparator
Oral dietary supplement. Instructions: Take 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

TKL Research

Fair Lawn, United StatesOpen TKL Research in Google Maps
Recruiting soonOne Study Center