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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
University of Alicante
Alicante, Spain
WEIGHT
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Time frame: 3 months
HEIGHT
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Time frame: 3 months
BLOOD PREASURE
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Time frame: 3 months
FAT MASS
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
Time frame: 3 months
VISCERAL FAT
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
Time frame: 3 months
BLOOD CORTISOL
Cortisol levels in blood by blood analysis.
Time frame: 3 months
SLEEP QUALITY
Measurement of sleep quality using the Pittsburgh sleep quality index.
Time frame: 3 months
STRESS
Measurement of perceived stress using the Perceived Stress Scale (PSS).
Time frame: 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.
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Time frame: 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.
Time frame: 3 months
HEART RATE
An electrocardiogram is used to obtain the heart rate.
Time frame: 3 months
SLEEP HOURS
Use of a FITBIT device to monitor the hours of sleep of each participant.
Time frame: 3 months