Study of the Effects of Plx on Bioparametric Measurements.

Study of the Anxiolytic Effects, Improvement of Sleep Quality and Bioparametric Measures in Individuals Taking an Extract of Lippia Citriodora.

The main objective is to study the effects of the intake of a nutraceutical on health indicators, focused on sleep and stress, as well as cardiovascular (blood pressure...), circulating (cortisol) and body composition parameters in a Spanish adult population.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Stress, Psychological; Sleep Initiation and Maintenance Disorders; Body Composition; Depression, Anxiety; Antidepressive Agents
• Intervention / Treatment: Dietary supplement: PLX

Detailed Description

Anxiety is a normal part of life, and generally is a temporary condition. However, anxiety can occasionally prolong in time, having an impact on everyday activities, and give rise to other conditions, such as depression, drug abuse, cardiovascular disease, and insomnia. There are a number of synthetic drugs that are commonly used to treat anxiety. These are mainly antidepressants and benzodiazepines. However, their high cost, important side effects and a rising interest in natural solutions have driven researchers to search for botanical-based formulas. To this end, there are a number of plants that have been described to possess potential sedative and anxiolytic effects. Of note is lemon verbena (Lippia citriodora), which is native of Western South America but is also cultivated in the Mediterranean region and Middle East.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03203
    • University of Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Over 21 years of age;
2. Without any chronic pathology;
3. Score on the Spielberg Trait-State Anxiety Inventory (STAI-S) comprising 20 items, greater than 40 (probable clinical levels of anxiety);
4. Pittsburgh Sleep Quality Index (PSQI) score greater than 5 (poor sleep quality).

Exclusion Criteria:

• Failure to meet the inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CONTROL GROUP; Nutraceutical placebo intake group	Dietary supplement: PLX; Intake of natural food supplement of vegetable origin based on lemon verbena extract (Lippia citriodora). To study the anxiolytic effects in subjects with high perceived stress levels and low sleep quality.
Experimental: PLX400mg GROUP; Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora).	Dietary supplement: PLX; Intake of natural food supplement of vegetable origin based on lemon verbena extract (Lippia citriodora). To study the anxiolytic effects in subjects with high perceived stress levels and low sleep quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WEIGHT	The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).	3 months
HEIGHT	The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).	3 months
BLOOD PREASURE	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.	3 months
FAT MASS	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.	3 months
VISCERAL FAT	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.	3 months
BLOOD CORTISOL	Cortisol levels in blood by blood analysis.	3 months
SLEEP QUALITY	Measurement of sleep quality using the Pittsburgh sleep quality index.	3 months
STRESS	Measurement of perceived stress using the Perceived Stress Scale (PSS).	3 months
ANXIETY	Measurement of perceived anxiety using the Spielberger Trait-State Anxiety Inventory questionnaire; it is an instrument created with the objective of assessing anxiety in two dimensions, state and trait.	3 months
PERCEIVED QUALITY OF LIFE	Measurement of quality of life using the World Health Organization Quality of Life (WHOQOL-BREF). The WHOQOL-BREF instrument provides a profile of quality of life, with each dimension or domain being scored independently. each dimension or domain scored independently. The higher the higher the score in each domain, the better the quality of life profile of the person being the person being assessed.	3 months
HEART RATE	An electrocardiogram is used to obtain the heart rate.	3 months
SLEEP HOURS	Use of a FITBIT device to monitor the hours of sleep of each participant.	3 months

Collaborators and Investigators

• Sponsor: University of Alicante
• Investigators: Principal Investigator: Alejandro Martinez Rodriguez, Assistant, Alicante University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Stress, Psychological
• Other Study ID Numbers: UA-2021-03-26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No