Impact of MetaCalm on Stress of Healthy People With Acute Stress
Evaluation of MetaCalm at Two Dose Levels in Healthy Adults With Acute Stress: An Open-Label, Non-Randomized Clinical Study
1 other identifier
interventional
280
1 country
1
Brief Summary
This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2026
CompletedFirst Posted
Study publicly available on registry
April 2, 2026
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
April 13, 2026
April 1, 2026
3 months
March 27, 2026
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Hunger, appetite and craving impacts
5 measurements in 6 hours
Other Outcomes (2)
Side effects experienced when taking the test product throughout the study (product tolerance)
At the of of the study, 6 hours after product administration
Patient satisfaction with product use and recommendation
At the of of the study, 6 hours after product administration
Study Arms (2)
2 chewable tablets of MetaCalm
ACTIVE COMPARATORSelection, 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 COMPARATORSelection, 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Metagenics, Inc.lead
- Metagenics Europecollaborator
Study Sites (1)
University of Molise
Campobasso, 86100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mieke Van Den Driessche
Metagenics, Inc.
- PRINCIPAL INVESTIGATOR
Sergio Davinelli, Professor
University of Molise (Italy)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2026
First Posted
April 2, 2026
Study Start
April 15, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share