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

Not Applicable

Not yet recruiting

• Conditions: Stress; Mood Disorders; Emotional Well-being

• Registration Number: NCT06942897
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Study First Posted: 2025-04-24
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Study Start: 2025-08-01
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in perceived stress levels measured by the Perceived Stress Scale (PSS)	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.