Study on a Dietary Supplement for Stress, Anxiety, Mood, and Sleep in Children
This study is looking at how a dietary supplement containing magnesium, L-theanine, and lemon balm extract might affect stress, anxiety, mood, and sleep in children aged 5 to 14 years old. Participants will either receive this dietary supplement or a placebo (an inactive substance that looks like the supplement). The main goal is to see if the supplement can improve feelings of stress compared to the placebo, using surveys. Researchers will also use questionnaires to measure changes in positive and negative emotions, and sleep habits. The study is looking for 80 healthy children who are currently attending school.
- Study design
- This is a randomized, placebo-controlled study, meaning participants will be randomly assigned to receive either the dietary supplement or a placebo. It plans to include 80 participants.
- What's involved
- Participants will take questionnaires at the beginning of the study and again after 4 weeks (28 days) of taking either the dietary supplement or placebo.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed at the end of the 4-week study period.
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A Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.from enrollment to end of study at Week 4
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.