AdultsNCT07507669
Impact of MetaCalm on Stress of Healthy People With Acute Stress
A study testing 2 chewable tablets of MetaCalm and 4 chewable tablets of MetaCalm in people with Adults and Acute Stress Reaction, run by Metagenics, Inc. at 1 site in Italy.
Trial summary
This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adults, Acute Stress Reaction
- What is being tested?
- 2 chewable tablets of MetaCalm and 4 chewable tablets of MetaCalm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Molise
Campobasso, 86100
Sergio Davinelli, MD, +39 0874 404774, sergio.davinelli@unimol.it
About this study
Official title: Evaluation of MetaCalm at Two Dose Levels in Healthy Adults With Acute Stress: An Open-Label, Non-Randomized Clinical Study
This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.
Read the 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.
- Conditions
- Adults, Acute Stress Reaction
- Being tested
- 2 chewable tablets of MetaCalm, 4 chewable tablets of MetaCalm
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 chewable tablets of MetaCalmDietary supplement
2 chewable tablets is administered orally at time T0 (during an episode of acute stress).
4 chewable tablets of MetaCalmDietary supplement
4 chewable tablets is administered orally at time T0 (during an episode of acute stress).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: 2 chewable tablets of MetaCalm |
| 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. Receives: Dietary Supplement: 4 chewable tablets of MetaCalm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 measurements in 6 hours
Secondary outcomes (1)
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.
Measured: 5 measurements in 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Metagenics Europe
- Responsible party
- Sponsor
- Investigators
- Mieke Van Den Driessche, Study director, Metagenics, Inc.Sergio Davinelli, Professor, Principal investigator, University of Molise (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507669
- Sponsor's protocol ID
- GLO-EU-2025-08
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MetaCalm at Two Dose Levels in Healthy Adults With Acute Stress: An Open-Label, Non-Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07507669
- Acronym / sponsor ID
- GLO-EU-2025-08
- Conditions
- Adults, Acute Stress Reaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Metagenics Europe
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 chewable tablets of MetaCalm | Active comparator | Dietary Supplement: 2 chewable tablets of MetaCalmSelection, 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 | Dietary Supplement: 4 chewable tablets of MetaCalmSelection, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 chewable tablets of MetaCalm2 chewable tablets is administered orally at time T0 (during an episode of acute stress). | Dietary supplement | 2 chewable tablets of MetaCalm |
| 4 chewable tablets of MetaCalm4 chewable tablets is administered orally at time T0 (during an episode of acute stress). | Dietary supplement | 4 chewable tablets of MetaCalm |
Primary outcome
STAI (State-Trait-Anxiety-Inventory) questionnaire
Time frame: 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.
1 secondary outcome
Hunger, appetite and craving impacts
Time frame: 5 measurements in 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mieke Van Den Driessche study director
Metagenics, Inc.
Sergio Davinelli, Professor principal investigator
University of Molise (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 chewable tablets of MetaCalm and 4 chewable tablets of MetaCalm in people with Adults and Acute Stress Reaction, run by Metagenics, Inc. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khadija Rhioui (+ 32 (0)59 29 50 30, EMEA_Trials@research.metagenics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI (State-Trait-Anxiety-Inventory) questionnaire (time frame: 5 measurements in 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.