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NCT Number: NCT07507669

Impact of MetaCalm on Stress of Healthy People With Acute Stress

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

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Key information

Conditions

Adults Acute Stress Reaction Mental Disorders Stress Disorders, Traumatic Stress Disorders, Traumatic, Acute Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

2 chewable tablets of MetaCalm

Dietary Supplement

2 chewable tablets is administered orally at time T0 (during an episode of acute stress).

4 chewable tablets of MetaCalm

Dietary Supplement

4 chewable tablets is administered orally at time T0 (during an episode of acute stress).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hunger, appetite and craving impacts

    Time frame: 5 measurements in 6 hours

    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.

Other outcomes

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

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

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

  2. Patient satisfaction with product use and recommendation

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

    The proportion of participants that at 6 hours (T4)

Study contacts

Contact information is provided by the study sponsor or research team.

Khadija Rhioui

CONTACT

[email protected]

+ 32 (0)59 29 50 30

Marie Garros

CONTACT

[email protected]

+ 32 (0)59 29 50 30

Sponsors and collaborators

Lead sponsor

Metagenics, Inc.

Industry

Collaborators

  • Metagenics Europe

Registry information

Official study title

Evaluation of MetaCalm at Two Dose Levels in Healthy Adults With Acute Stress: An Open-Label, Non-Randomized Clinical Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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