Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Variation in sleep quality from baseline at 12 weeks.
研究概览
简要总结
Randomized, controlled, double-blind, single-center clinical trial with two parallel arms depending on the product consumed (experimental product and placebo product) to analyze the efficacy of a botanical extract in reducing anxiety and improving sleep quality.
详细描述
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose or placebo, depending on the group to which they have been assigned).
The product to be consumed is a botanical extract. Participants will consume the product for 90 days. They should consume one capsule one hour before going to sleep.
They will make a total of five visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults.
- •Moderate levels of anxiety by STAI.
- •Low sleep quality by PSQI.
- •Volunteers able to understand the clinical study and willing to comply with its procedures and requirements.
排除标准
- •Serious or terminal illness.
- •Subjects with body mass index above 32 kg/m
- •Pregnant or lactating women.
- •Participation in another study involving blood draws or dietary intervention.
- •Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia.
- •Hypersensitivity to the components of the formula.
- •Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs.
- •Subjects with known allergy to some of the study components.
- •Inability to understand the informed consent.
结局指标
主要结局
Variation in sleep quality from baseline at 12 weeks.
时间窗: The evolution of sleep quality after consumption during 12 weeks will be measured.
Visual analog scale from 0 to 10. The higher the value, the more quality.
次要结局
- Anxiety questionnaire(Day 1, at 12 weeks later)
- Change in Sleep Quality from baseline at 12 weeks(Sleep quality will be measured with a daily scale, from baseline to 12 weeks.)
- Melatonine(It will be measured twice, once at baseline or at the end of the study after 12 weeks of use)
- Liver safety variables(It will be measured twice, once at baseline or at the end of the study after 12 weeks.)
- Adverse events(At 12 weeks after consumption)
- Sleep quality(It will be measured twice, once at baseline or at the end of the study after 12 weeks of use)
- Sleep efficiency(It will be measured during 4 working days and one weekend day, before starting the consumption of the product and before the end of consumption (90 days).)
- Perceived stress scale(Day 1, at 12 weeks later)
- Cortisol(It will be measured twice, once at baseline or at the end of the study after 12 weeks of use)
- Body composition(The test will be measured at baseline and after 12 weeks of consumption.)
- Physical activity control(It will be measured during 4 working days and one weekend day, before starting the consumption of the product and before the end of consumption (90 days).)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia