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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
280
2 chewable tablets is administered orally at time T0 (during an episode of acute stress).
4 chewable tablets is administered orally at time T0 (during an episode of acute stress).
University of Molise
Campobasso, Italy
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.
Time frame: 5 measurements in 6 hours
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.
Time frame: 5 measurements in 6 hours
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