Study of the Effects of Plx on Bioparametric Measurements.

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128812
• Other study ID #: UA-2021-03-26
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2023
• Source: University of Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antidepressive Agents
• Body Composition
• Depression, Anxiety
• Quality of Life
• Sleep Initiation and Maintenance Disorders
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Spain	University of Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WEIGHT	The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).	3 months
Primary	HEIGHT	The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).	3 months
Primary	BLOOD PREASURE	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.	3 months
Primary	FAT MASS	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.	3 months
Primary	VISCERAL FAT	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.	3 months
Primary	BLOOD CORTISOL	Cortisol levels in blood by blood analysis.	3 months
Primary	SLEEP QUALITY	Measurement of sleep quality using the Pittsburgh sleep quality index.	3 months
Primary	STRESS	Measurement of perceived stress using the Perceived Stress Scale (PSS).	3 months
Primary	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
Primary	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
Primary	HEART RATE	An electrocardiogram is used to obtain the heart rate.	3 months
Primary	SLEEP HOURS	Use of a FITBIT device to monitor the hours of sleep of each participant.	3 months