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

NCT06942897 | Not Yet Recruiting

• 1 other identifier: 1267/21092023
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Mood Disorders; Emotional Well-being

Outcome Measures

Primary Outcomes (1)

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

  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)

Study Arms (1)

Melissa Officinalis Supplement

EXPERIMENTAL

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

Interventions

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.

Melissa Officinalis Supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-04