Study of the Effects of Plx on Bioparametric Measurements.
- Conditions
- Depression, AnxietyStress, PsychologicalSleep Initiation and Maintenance DisordersBody CompositionQuality of LifeAntidepressive Agents
- Interventions
- Dietary Supplement: PLX
- Registration Number
- NCT05128812
- Lead Sponsor
- University of Alicante
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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).
- Failure to meet the inclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CONTROL GROUP PLX Nutraceutical placebo intake group PLX400mg GROUP PLX Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora).
- Primary Outcome Measures
Name Time Method HEIGHT 3 months The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
BLOOD PREASURE 3 months Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
PERCEIVED QUALITY OF LIFE 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.
FAT MASS 3 months Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
HEART RATE 3 months An electrocardiogram is used to obtain the heart rate.
VISCERAL FAT 3 months Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
WEIGHT 3 months The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
SLEEP QUALITY 3 months Measurement of sleep quality using the Pittsburgh sleep quality index.
SLEEP HOURS 3 months Use of a FITBIT device to monitor the hours of sleep of each participant.
ANXIETY 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.
BLOOD CORTISOL 3 months Cortisol levels in blood by blood analysis.
STRESS 3 months Measurement of perceived stress using the Perceived Stress Scale (PSS).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Alicante
🇪🇸Alicante, Spain