Evaluation of a Dietary Supplement Containing Melissa Officinalis Formulated in Phospholipids on Mood Well-being and Cortisol Modulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAzienda di Servizi alla Persona di Pavia

About this trial

This is a randomized, double-blind, placebo-controlled pilot study designed to evaluate the effect of an oral nutritional supplement containing Melissa officinalis formulated in phospholipids on mood and cortisol levels in healthy adults. Participants will be randomly assigned to receive either the active supplement or a placebo daily for 3 weeks. The primary outcome measures include changes in mood well-being, perceived stress, and salivary cortisol levels. The study aims to assess both efficacy and safety of the supplement in modulating stress response and emotional balance.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 65 years

Healthy volunteers as assessed by medical history and physical examination

Willingness to comply with the study procedures

Disqualifiers

Current use of medications or supplements that may affect mood or cortisol levels

Known allergy or sensitivity to Melissa officinalis or phospholipids

History of psychiatric disorders (e.g., major depression, anxiety disorders)

Significant comorbidities (e.g., cardiovascular, hepatic, renal diseases)

Trial design

Design model

Single group

Treatments tested in this trial

  • Melissa officinalis supplement

    Dietary supplement

    This intervention consists of a standardized oral dietary supplement containing 400 mg of Melissa officinalis extract formulated in phospholipids. The supplement is administered once daily for 3 weeks to evaluate its potential effects on mood, stress perception, and cortisol levels in healthy adults.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Melissa Officinalis SupplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in perceived stress levels measured by the Perceived Stress Scale (PSS)

The PSS is a validated 10-item questionnaire that assesses the perception of stress over the past month. Scores range from 0 to 40, with higher scores indicating greater stress. The change from baseline to 3 weeks will be measured.

Time frame
week 4 (after 3 weeks of intervention)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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