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

NCT07076537 | Not Yet Recruiting

• 1 other identifier: ULOLLYKC2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.

  PSS-children will be administered before the intervention to establish baseline, 40 min after taking the initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement in stress levels across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on the scales The PSS-C: (perceived stress scale -children form) 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.

  from enrollment to end of study at Week 4

Secondary Outcomes (2)

• To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire.

  from enrollment to end of study at Week 4

• To assess the efficacy for improvement of sleep quality compared to placebo through validated survey questionnaire.

  from enrollment to end of study at Week 4

Study Arms (2)

Placebo

PLACEBO 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.

Dietary Supplement: Placebo

Dietary Supplement with actives

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.

Dietary Supplement: Dietary Supplement with actives

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Dietary Supplement with actives DIETARY_SUPPLEMENT

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

Dietary Supplement with actives

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Ability to give consent (assent) for participation in the study

You may not qualify if:

• 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
• History of reaction to the category of product tested
• Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• 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.
• 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.
• Subjects with a history of cancer within the past 5 years.
• Subjects with any planned surgeries and/or invasive medical procedures during the study.
• Individuals unable to communicate or cooperate with the principal investigator due to language
• Employees (and children of employees) of TKL and/or product brand owner or manufacturer.

Sponsors & Collaborators

• Olly, PBC: lead

Study Sites (1)

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 22, 2025
• Study Start: July 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 2, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

US (1)