Study of the Anxiolytic Effects, Improvement of Sleep Quality and Bioparametric Measures in Individuals Taking an Extract of Lippia Citriodora.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SLEEP QUALITY
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Failure to meet the inclusion criteria.
研究组 & 干预措施
CONTROL GROUP
Nutraceutical placebo intake group
干预措施: PLX (Dietary Supplement)
PLX400mg GROUP
Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora).
干预措施: PLX (Dietary Supplement)
结局指标
主要结局
SLEEP QUALITY
时间窗: 3 months
Measurement of sleep quality using the Pittsburgh sleep quality index.
PERCEIVED QUALITY OF LIFE
时间窗: 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.
ANXIETY
时间窗: 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.
SLEEP HOURS
时间窗: 3 months
Use of a FITBIT device to monitor the hours of sleep of each participant.
HEART RATE
时间窗: 3 months
An electrocardiogram is used to obtain the heart rate.
VISCERAL FAT
时间窗: 3 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
WEIGHT
时间窗: 3 months
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
FAT MASS
时间窗: 3 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
HEIGHT
时间窗: 3 months
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
BLOOD PREASURE
时间窗: 3 months
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
BLOOD CORTISOL
时间窗: 3 months
Cortisol levels in blood by blood analysis.
STRESS
时间窗: 3 months
Measurement of perceived stress using the Perceived Stress Scale (PSS).
次要结局
未报告次要终点
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Assistant Professor
University of Alicante