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

November 23, 2025 updated by: Azienda di Servizi alla Persona di Pavia

Pilot Study for the 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melissa Officinalis Supplement
Participants will receive a dietary supplement containing 400 mg of Melissa officinalis formulated in phospholipids once daily for 3 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 4 (after 3 weeks of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda di Servizi alla Persona di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1267/21092023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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