Emotional Well-being, Mood Disorders, Stress
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMelissa 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.
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed