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

Part of paid clinical trials in Fair Lawn, New Jersey.

Sponsor
Olly, PBC
Study ID
NCT07076537
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
5 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DIETARY_SUPPLEMENT
    Placebo
  • Dietary Supplement with actives — DIETARY_SUPPLEMENT
    Dietary Supplement containing magnesium, L-theanine and lemon balm extract

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
Jul 2025
Primary completion
Aug 15, 2025
Completion
Sep 2, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: 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.
  • Active Comparator: Dietary Supplement with actives
    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.

Primary Outcome Measure

To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire. [ Time Frame: from enrollment to end of study at Week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
TKL ResearchFair LawnNew Jersey07410
John Lyssikatos

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By research site
TKL Research· Fair Lawn, NJ

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