A Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
Olly, PBC
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.
Description
For these scale, here are some more details: The PSS-C: 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. The PANAS-C: Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in: * Positive Affect (PA): 15 to 75 * Negative Affect (NA): 15 to 75 Interpretation: Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse ou…
Eligibility
- Age range
- 5–14 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Willingness to actively participate in the study and to come to the scheduled visits. 2. 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. 3. Enrolled in and currently attending school at baseline and for the duration of the study period. 4. 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. 5. Ability to give consent (assent) for participation in the stu…
Interventions
- Dietary SupplementPlacebo
Placebo
- Dietary SupplementDietary Supplement with actives
Dietary Supplement containing magnesium, L-theanine and lemon balm extract
Location
- TKL ResearchFair Lawn, New Jersey