Acute Stress Reaction, Adults
Conditions
Brief summary
This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENT2 chewable tablets of MetaCalm
2 chewable tablets is administered orally at time T0 (during an episode of acute stress).
DIETARY_SUPPLEMENT4 chewable tablets of MetaCalm
4 chewable tablets is administered orally at time T0 (during an episode of acute stress).
Sponsors
Metagenics, Inc.
Metagenics Europe
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Providing written informed consent * Males and females of at least 18 years old * Obtaining a reference score of ≥ 30 on the STAI questionnaire (State-Trait Anxiety Inventory, short version, 10-item scale)
Exclusion criteria
* Being on anxiolytic and beta blocker treatment * Individuals who use illicit or recreational drugs * Having consumed adaptogen plants in one week prior to enrollment * Participating in another clinical trial * Patients diagnosed with cancer * Allergic to any of the ingredients in this product * Obtaining a reference score of less than 30 on the STAI questionnaire (State-Trait Anxiety Inventory, short version, 10-item scale)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STAI (State-Trait-Anxiety-Inventory) questionnaire | 5 measurements in 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hunger, appetite and craving impacts | 5 measurements in 6 hours | 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. |
Countries
Italy
Contacts
CONTACTKhadija Rhioui
CONTACTMarie Garros
STUDY_DIRECTORMieke Van Den Driessche
Metagenics, Inc.
PRINCIPAL_INVESTIGATORSergio Davinelli, Professor
University of Molise (Italy)
Outcome results
None listed