Skip to main content
OpenTrials
Completed

NCT Number: NCT05128812

Study of the Effects of Plx on Bioparametric Measurements.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Quality of Life Antidepressive Agents Anxiety Disorders Behavior Behavioral Symptoms Body Composition Depression Depression, Anxiety Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress, Psychological

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alicante

Alicante, 03203, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Failure to meet the inclusion criteria.

Treatment and study plan

PLX

Dietary Supplement

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.

Primary outcomes

  1. WEIGHT

    Time frame: 3 months

    The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).

  2. HEIGHT

    Time frame: 3 months

    The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).

  3. BLOOD PREASURE

    Time frame: 3 months

    Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.

  4. FAT MASS

    Time frame: 3 months

    Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.

  5. VISCERAL FAT

    Time frame: 3 months

    Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.

  6. BLOOD CORTISOL

    Time frame: 3 months

    Cortisol levels in blood by blood analysis.

  7. SLEEP QUALITY

    Time frame: 3 months

    Measurement of sleep quality using the Pittsburgh sleep quality index.

  8. STRESS

    Time frame: 3 months

    Measurement of perceived stress using the Perceived Stress Scale (PSS).

  9. ANXIETY

    Time frame: 3 months

    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.

  10. PERCEIVED QUALITY OF LIFE

    Time frame: 3 months

    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.

  11. HEART RATE

    Time frame: 3 months

    An electrocardiogram is used to obtain the heart rate.

  12. SLEEP HOURS

    Time frame: 3 months

    Use of a FITBIT device to monitor the hours of sleep of each participant.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 22, 2021
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.