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Not yet recruiting NCT06942897

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

No phase Interventional Stress Mood Disorders Emotional Well-being

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Melissa officinalis supplement.
Who it may be relevant to
Registry conditions: Stress, Mood Disorders, Emotional Well-being. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Dietary supplement Melissa officinalis 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.

Primary outcome measures

  • Change in perceived stress levels measured by the Perceived Stress Scale (PSS) [Time frame: week 4 (after 3 weeks of intervention)]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 65 years
  • Healthy volunteers as assessed by medical history and physical examination
  • Willingness to comply with the study procedures

Exclusion criteria

  • 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)
  • Pregnant or breastfeeding women
  • Participation in another clinical trial in the past 30 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06942897 · 1267/21092023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗