Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Compare the polysomnography of participants with insomnia
研究概览
简要总结
This study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood.
详细描述
This study will consist of 4 visits - 1 screening visit and 3 treatment visits. Screening visit will consist of a fasting chemistry panel, a health questionnaire, an Insomnia Severity Index, the Epworth Sleepiness Scale, the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State-Trait Anxiety Inventory, and the Fatigue Severity Scale.
Ten subjects passing screening will take for 2 weeks between dinner and bedtime in a blinded and balanced order: 1. Eight ounces of cherry juice standardized to its proanthocyanidin content in the morning and 8 ounces of cherry juice standardized to its procyanidin content 1-2 hours before bedtime for 14 days; 2. A similar amount of placebo juice with the same timing for the cross-over. There will be a 2-week washout between each of the treatment periods. Subjects will be scheduled for two overnight PSGs, one at the end of each two-week treatment period. On the morning following each test the insomnia severity index and other questionnaires will be repeated. The order of the placebo juice and cherry juice will be random and balanced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female with a usual bedtime between 9 pm and midnight.
- •65 years of age or older.
- •Sleep problem >3 nights per week, meeting the International Classification of Sleep Disorders (ICSD-2*) diagnostic criteria of insomnia for at least 6 months.
- •An insomnia severity index ≥ 10 and a minimum of 30 minutes of either sleep-onset latency (SL) or wake after sleep onset (WASO).
- •*ICSD-2 general criteria for insomnia:
- •A complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically non-restorative or poor in quality.
- •The above sleep difficulty occurs despite adequate opportunity and circumstances for sleep.
- •At least one of the following forms of daytime impairment related to the nighttime sleep difficulty is reported by the patient:
- •Fatigue or malaise.
- •Attention, concentration, or memory impairment.
- •Social or vocational dysfunction or poor school performance.
- •Mood disturbance or irritability.
- •Daytime sleepiness.
- •Motivation, energy, or initiative reduction.
- •Proneness for errors or accidents at work or while driving.
- •Tension, headaches, or gastrointestinal symptoms in response to sleep loss.
- •Concerns or worries about sleep.
排除标准
- •Diabetes.
- •Sedating or hypnotic medications.
- •Any chronic medication that has not had a stable dose for 1 month or longer.
结局指标
主要结局
Compare the polysomnography of participants with insomnia
时间窗: Baseline and Week 4
Compare the polysomnography of participants with insomnia on a night at the end of 2 weeks taking: Eight ounces of standardized cherry juice vs. the night taking the placebo juice.
次要结局
- Comparison of insomnia sleep scales(Baseline and Week 4)
- Differences in the enzyme blood test(Baseline, Week 2 & Week 4)
- Compare the Insomnia Severity Index and validated questionnaires(Baseline and Week 4)
研究者
Frank Greenway
Principal Investigator
Pennington Biomedical Research Center