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

NCT ID: NCT06942897

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-15

Study Completion Date

2026-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Mood Disorders Emotional Well-being

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Melissa Officinalis Supplement

Participants will receive a dietary supplement containing 400 mg of Melissa officinalis formulated in phospholipids once daily for 3 weeks.

Group Type EXPERIMENTAL

Melissa officinalis supplement

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1267/21092023

Identifier Type: -

Identifier Source: org_study_id

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