Analysis of the Efficacy of Different Types of Milk Enriched With Tryptophan and Supplemented With Ashwagandha Extract in Improving Sleep Quality in Subjects With Sleep Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 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 intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.
详细描述
The duration of the study will be 90 days (12 weeks). Each day they will have to consume the product under investigation. The subjects who meet the selection criteria will be randomly distributed in each of the study groups (A, B, C or D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary on sleep quality and concomitant medication.
They will make a total of two 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 (> 18 years).
- •Low sleep quality by Pittsburgh Sleep Quality Questionnaire (PSQI).
- •Volunteers able to understand the clinical study and willing to comply with the study procedures and requirements.
排除标准
- •Subjects with serious or terminal illnesses.
- •Subjects with known allergy or hypersensitivity to any of the components of the investigational product.
- •Participation in another study involving blood draws or dietary intervention.
- •Subjects with body mass index above 32 kg/m
- •Pregnant or lactating women.
- •Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs.
- •Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia.
- •Inability to understand informed consent (IC).
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
- Change in Sleep Quality from baseline at 12 weeks(Sleep quality will be measured with a daily scale, from baseline to 12 weeks.)
- Sleep quality(It will be measured twice, once at baseline or at the end of the study after 12 weeks of use)
- Anxiety questionnaire(Day 1, at 12 weeks later)
- Sleepiness(It will be measured twice, once at baseline or at the end of the study after 12 weeks of use)
- Matutinity - Verpertinity(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.)
- Insomnia severity(It will be measured twice, once at baseline or at the end of the study after 12 weeks of use)
- Adverse events(At 12 weeks after consumption)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia