Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL GROUP | Placebo Comparator | Nutraceutical placebo intake group |
|
| PLX400mg GROUP | Experimental | Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Martinez Rodriguez, Assistant | Alicante University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alicante | Alicante | 03203 | Spain |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |