Health TrialsbyHealthPanel

Impact of MetaCalm on Stress of Healthy People With Acute Stress

ConditionsAdultsAcute Stress Reaction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetagenics, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: 2 chewable tablets of MetaCalmActive comparator 1 intervention
Group B: 4 chewable tablets of MetaCalmActive comparator 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Metagenics, Inc.

Lead sponsor

Metagenics Europe

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: