Effects of Melissa Extract on Sleep Characteristics

NCT05950932 | Unknown Phase 4

• 1 other identifier: UniUrb_Melissa_2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The plant Melissa officinalis L. is commonly used to treat disorders related to anxiety and sleep quality. It contains several phytochemicals that give it antioxidant, anti-inflammatory, antispasmodic, antimicrobial, and neuroprotective properties. A study on subjects with mild to moderate anxiety and sleep disorders showed that an extract of Melissa officinalis reduced anxiety manifestations by 18%, improved symptoms associated with anxiety by 15%, and reduced insomnia by 42%. However, that study did not have a control group, so a randomized trial with a control group is needed. The objective of the study will be to evaluate the beneficial effects of a phytosome-formulated Melissa officinalis extract on sleep duration and different stages of sleep, which will be monitored using a wrist device. She will be provided with a wrist device that will be used for sleep monitoring. The trial will last for 45 days, in which she will be asked to take the phytosome-formulated Melissa supplement for two 14-day periods (2 tablets, 30 minutes before bedtime). There will be a 7-day break in the intake period between the two periods. At the beginning, middle, and end of the trial, you will be asked to answer some questionnaires.

Conditions

Sleep Disorder; Anxiety; Quality of Life

Keywords

sleep quality; quality of life; plant extract; melissa officinalis

Outcome Measures

Primary Outcomes (1)

• Sleep duration (hours and minutes)

  The sleep duration will be assessed as primary outcome, considering the total sleep time and the time spent in different sleeping phases.

  From Day 0 to Day 36

Secondary Outcomes (4)

• Perceived sleep quality (score)

  Day 0, Day 15, Day 36.

• Perceived Anxiety (score)

  Day 0, Day 15, Day 36

• Quality of life (score)

  Day 0, Day 15, Day 36

• Adverse symptoms (number and severity)

  From Day 0 to Day 36.

Study Arms (2)

Treatment-Placebo

EXPERIMENTAL

This arm will assume firstly the supplement product (Melissa phytosome) and later the placebo.

Dietary Supplement: Melissa phytosome; Other: Placebo

Placebo-Treatment

EXPERIMENTAL

This arm will assume firstly the placebo and later the supplement product (Melissa phytosome).

Dietary Supplement: Melissa phytosome; Other: Placebo

Interventions

Melissa phytosome DIETARY_SUPPLEMENT

Melissa phytosome® is composed of dry extract of Berberis aristata root (550mg/cpr), complexed with phospholipids (soy lecithin), Pisum sativa proteins, and proanthocyanidin oligomers from Vitis vinifera. 2 tablets of 200 mg Melissa phytosome will be provided to participants, to be taken 30 minutes before bedtime for 14 days.

Placebo-Treatment; Treatment-Placebo

Placebo OTHER

2 tablets with an equivalent form, color, flavor, and coating as the experimental product, to take 30 minutes before bedtime.

Placebo-Treatment; Treatment-Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• Diagnosis of insomnia or sleep disturbances anxiety-related, since at least 30 days.

You may not qualify if:

• Breastfeeding
• Intention to become pregnant during the course of the study
• Consumption of anxiolytics, antidepressants, hypnotics, or sedatives within 10 days prior to the start of the study
• Diabetes
• Asthma
• Hypo- and hyperthyroidism
• Diagnosis of psychiatric and neurological disorders
• Treatment with psychotropic medications
• Treatment with antihistamines
• Alcoholism
• Smoking
• Current or past use of narcotics
• Use of melatonin
• Use of herbal remedies for sleep disorders.

Sponsors & Collaborators

• University of Urbino "Carlo Bo": lead
• University of Pavia: collaborator

Study Sites (1)

University of Urbino Carlo Bo

Urbino, 61029, Italy

Location

Related Publications (1)

• Cases J, Ibarra A, Feuillere N, Roller M, Sukkar SG. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition Metab. 2011 Dec;4(3):211-218. doi: 10.1007/s12349-010-0045-4. Epub 2010 Dec 17.

  PMID: 22207903 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Davide Sisti, PhD

CONTACT

+39-0722-303301; davide.sisti@uniurb.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants and the evaluators enrolling the participants will be blinded to the treatment conditions. The verum and placebo products will be packaged in indistinguishable separate containers, labeled with alphanumeric codes, and placed inside a dedicated kit. The alphanumeric keys related to the classification of products as treated/placebo will only be made available to the researchers after the data processing has been completed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The treatment order (Melissa phytosome or placebo) will be randomly assigned using a binary random sequence generated through appropriate programming on an electronic spreadsheet. The order of phytosome/placebo administration will be achieved through block randomization (block size = 4), with participant stratification based on gender.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)