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

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.

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Key information

Conditions

Stress Emotional Well-being Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: week 4 (after 3 weeks of intervention)

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.

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 24, 2025
Registry last updated: Nov 25, 2025

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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