Impact of MetaCalm on Stress of Healthy People With Acute Stress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2 chewable tablets of MetaCalm, 4 chewable tablets of MetaCalm.
- Who it may be relevant to
- Registry conditions: Adults, Acute Stress Reaction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of MetaCalm at Two Dose Levels in Healthy Adults With Acute Stress: An Open-Label, Non-Randomized Clinical Study
Overview
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 supplement 2 chewable tablets of MetaCalm
2 chewable tablets is administered orally at time T0 (during an episode of acute stress). - Dietary supplement 4 chewable tablets of MetaCalm
4 chewable tablets is administered orally at time T0 (during an episode of acute stress).
Primary outcome measures
- STAI (State-Trait-Anxiety-Inventory) questionnaire [Time frame: 5 measurements in 6 hours]
Secondary outcome measures (1)
- Hunger, appetite and craving impacts [Time frame: 5 measurements in 6 hours]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- University of Molise — Campobasso
Identifiers
NCT: NCT07507669 · GLO-EU-2025-08