Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Interpretation:
Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)
The CSHQ Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99.
Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo |
| |
| Dietary Supplement with actives |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire. | PANAS-children questionnaire will be administered before the intervention, to establish baseline, 40 min after initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement of positive and negative mood across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on scale: The PANAS-C: (positive and negative affect scale-children form) Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in:
Interpretation: Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research | Fair Lawn | New Jersey | 07410 | United States |
Not provided
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
Dietary Supplement containing magnesium, L-theanine and lemon balm extract |
|
| 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. | CSHQ questionnaire will be administered before the intervention, to establish baseline, and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement sleep quality across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on scale: The CSHQ (children sleep habits questionnaire) Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99. Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome. | from enrollment to end of study at Week 4 |