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

This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.

Study Overview

• Status: Not yet recruiting
• Conditions: Adults; Acute Stress Reaction
• Intervention / Treatment: Dietary supplement: 2 chewable tablets of MetaCalm; Dietary supplement: 4 chewable tablets of MetaCalm

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 Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khadija Rhioui; Phone Number: + 32 (0)59 29 50 30; Email: EMEA_Trials@research.metagenics.com
• Study Contact Backup: Name: Marie Garros; Phone Number: + 32 (0)59 29 50 30; Email: EMEA_Trials@research.metagenics.com

Study Locations

• Italy
  • Campobasso, Italy, 86100
    • University of Molise
    • Contact: Sergio Davinelli, MD; Phone Number: +39 0874 404774; Email: sergio.davinelli@unimol.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 2 chewable tablets is administered orally at time T0 (during an episode of acute stress).
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; 4 chewable tablets is administered orally at time T0 (during an episode of acute stress).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 measurements in 6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the of of the study, 6 hours after product administration
Patient satisfaction with product use and recommendation	The proportion of participants that at 6 hours (T4)	At the of of the study, 6 hours after product administration

Collaborators and Investigators

• Sponsor: Metagenics, Inc.
• Collaborators: Metagenics Europe
• Investigators: Study Director: Mieke Van Den Driessche, Metagenics, Inc.; Principal Investigator: Sergio Davinelli, Professor, University of Molise (Italy)

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Traumatic, Acute
• Other Study ID Numbers: GLO-EU-2025-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No