A Cross-over Pilot Trial to Determine the Effect of an LSU Patented Dietary Herbal Supplement on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Chubon Lifestyle Score
研究概览
简要总结
The purpose of this research study is to evaluate the effect of a combination of 3 food components to improve the quality of life in people who have trouble sleeping. Ten subjects with insomnia will drink 2 ounces of the supplement or a placebo for 1 week and after a 2 weeks washout period, will take the treatment they did not take the first week. Questionnaires to evaluate quality of life, and a sleep study will be done before and after each treatment week.
详细描述
Each participant will be in the study for about 1 month. The questionnaires consist of Chubon Quality of Life Rating, the Multi-dimensional Fatigue Inventory, Insomnia Severity Index, the Epworth Sleepiness, Pittsburgh Sleep Quality Index. Subjects will be screened with a medical questionnaire, vital signs, height, weight, oximetry to identify sleep apnea, a CBC and chemistry panel and the Insomnia severity Index. Weight, vital signs, adverse event questioning, dispensing and collection of test material will be done at each visit. During each treatment week subjects will wear an actigraph, keep a sleep diary and at the beginning and end of each treatment week subjects will have a polysomnography. At the end of each treatment period subjects will have a chemistry panel, a CBC, and a buffy coat will be archived.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Liquid that looks and tastes the same, but only one has the three food components. The order in which the subjects get the 3-component supplement and the placebo is randomly assigned and balanced.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women >50 years of age
- •Usual bedtime between 9pm and midnight
- •Insomnia for >6months by ICSD-2 criteria
- •Insomnia Severity Index score >10 and Sleep-onset latency or Waking after sleep onset >30 minutes
排除标准
- •Have diabetes mellitus
- •Taking chronic medication not on a stable dose for >1month
- •Taking sedating or hypnotic medications
- •Have a sleep disorder other than insomnia (like sleep apnea) Adults unable to consent Prisoners Pregnant women Individuals not yet adults
研究组 & 干预措施
Dietary supplement
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
干预措施: Dietary supplement (Dietary Supplement)
Placebo
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
干预措施: Dietary supplement (Dietary Supplement)
结局指标
主要结局
Chubon Lifestyle Score
时间窗: 1 week
Total score ranges from 20 to 140 with higher scores being better quality of life
次要结局
- Multidimensional Fatigue Index - Physical Fatigue(1 week)
- Pittsburgh Sleep Quality Index Score(1 week)
- Epworth Sleepiness Scale(1 week)
- Multidimensional Fatigue Index -General Fatigue(1-week)
- Multidimensional Fatigue Index - Mental Fatigue(1 week)
研究者
Frank Greenway
Professor, Chief Medical Officer
Pennington Biomedical Research Center