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

A

Azienda di Servizi alla Persona di Pavia

Status

Begins enrollment in 4 months

Conditions

Emotional Well-being
Mood Disorders
Stress

Treatments

Dietary Supplement: Melissa officinalis supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT06942897
1267/21092023

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Melissa Officinalis Supplement
Experimental group
Description:
Participants will receive a dietary supplement containing 400 mg of Melissa officinalis formulated in phospholipids once daily for 3 weeks.
Treatment:
Dietary Supplement: Melissa officinalis supplement

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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