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| Name | Class |
|---|---|
| Metagenics Europe | INDUSTRY |
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This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.
The trial begins with a screening process to assess eligibility for the study. Participants will then receive 2 or 4 MetaCalm chewable tablets, followed by a 6-hour phase during which they will be asked to complete several questionnaires at different times after taking the tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 chewable tablets of MetaCalm | Active Comparator | Selection, during which eligibility to participate in the trial takes place at the start of the study: A single dose of 2 chewable tablets is administered. |
|
| 4 chewable tablets of MetaCalm | Active Comparator | Selection, during which eligibility to participate in the trial takes place at the start of the study: A single dose of 4 chewable tablets is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 chewable tablets of MetaCalm | Dietary Supplement | 2 chewable tablets is administered orally at time T0 (during an episode of acute stress). |
|
| Measure | Description | Time Frame |
|---|---|---|
| STAI (State-Trait-Anxiety-Inventory) questionnaire | To assess the impact of MetaCalm on stress using a validated questionnaire, the State-Trait Anxiety Inventory (STAI) for adults. Depending on the patient's stress levels, scores will range from 10 to 40. The higher the score, the more stressed the patient is considered to be. | 5 measurements in 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger, appetite and craving impacts | Assess the effect of MetaCalm on hunger, appetite and the urge to snack using questions asked over a 6-hour period. Depending on your answers, scores will range from 7 to 45. The higher the score, the greater your hunger, appetite and urge to snack will be. | 5 measurements in 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects experienced when taking the test product throughout the study (product tolerance) | The proportion of participants at 6 hours (T4) that expressed any of the following symptoms | At the of of the study, 6 hours after product administration |
| Patient satisfaction with product use and recommendation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khadija Rhioui | Contact | + 32 (0)59 29 50 30 | EMEA_Trials@research.metagenics.com | |
| Marie Garros | Contact | + 32 (0)59 29 50 30 | EMEA_Trials@research.metagenics.com |
| Name | Affiliation | Role |
|---|---|---|
| Mieke Van Den Driessche | Metagenics, Inc. | Study Director |
| Sergio Davinelli, Professor | University of Molise (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Molise | Campobasso | 86100 | Italy |
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| ID | Term |
|---|---|
| D040701 | Stress Disorders, Traumatic, Acute |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 4 chewable tablets of MetaCalm | Dietary Supplement | 4 chewable tablets is administered orally at time T0 (during an episode of acute stress). |
|
The proportion of participants that at 6 hours (T4) |
| At the of of the study, 6 hours after product administration |