ClinicalTrials.gg
Not yet recruitingNCT07507669Updated Apr 13, 2026

Impact of MetaCalm on Stress of Healthy People With Acute Stress

An interventional study of 2 chewable tablets of MetaCalm and 4 chewable tablets of MetaCalm in Adults and Acute Stress Reaction, sponsored by Metagenics, Inc.. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Metagenics, Inc. · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adults
  • Acute Stress Reaction
03

In context

Stress Disorders, Traumatic, Acute

58 studies on the registry are indexed under Stress Disorders, Traumatic, Acute; 15 are open to participants now.

This study's planned enrollment of 280 is above the median of 91 across 52 interventional studies indexed under Stress Disorders, Traumatic, Acute.

Browse Stress Disorders, Traumatic, Acute studies →

Lead sponsor

Metagenics, Inc. is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Providing written
  • 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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Active comparator
    2 chewable tablets of MetaCalm

    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.

    Dietary Supplement: 2 chewable tablets of MetaCalm

  • Active comparator
    4 chewable tablets of MetaCalm

    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.

    Dietary Supplement: 4 chewable tablets of MetaCalm

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).

06

What researchers measure

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.

    Time frame: 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.

    Time frame: 5 measurements in 6 hours

Other outcomes

  1. Side effects experienced when taking the test product throughout the study (product tolerance)

    The proportion of participants at 6 hours (T4) that expressed any of the following symptoms

    Time frame: At the of of the study, 6 hours after product administration

  2. Patient satisfaction with product use and recommendation

    The proportion of participants that at 6 hours (T4)

    Time frame: At the of of the study, 6 hours after product administration

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Jun 2026, 2 months later.

Of 25 interventional studies with no phase under Stress Disorders, Traumatic, Acute, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2026
First posted
Apr 2, 2026
StartEst.
Apr 15, 2026
Primary completionEst.
Jun 30, 2026
CompletionEst.
Aug 31, 2026
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07507669
Lead sponsor
Metagenics, Inc.
Collaborators
Metagenics Europe
Responsible party
Sponsor
First posted
Apr 2, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Apr 13, 2026

Study contacts

Khadija Rhioui
Contact
EMEA_Trials@research.metagenics.com
+ 32 (0)59 29 50 30
Marie Garros
Contact
EMEA_Trials@research.metagenics.com
+ 32 (0)59 29 50 30
Mieke Van Den Driessche
study director · Metagenics, Inc.
Sergio Davinelli, Professor
principal investigator · University of Molise (Italy)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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