Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The purpose of this research study is test if a study that asks older adults with sleep problems to consume tart cherry products is feasible and determine if it can change sleep patterns. This study is a total of 12 weeks. Participants will be asked to consume tart cherry juice for 4 weeks and the placebo juice for 4 weeks, while wearing a digital monitor that measures sleep. Blood (about 3 teaspoons) and urine (about 2 tablespoons) samples will be taken before and after consuming both juices to measure certain biological markers related to sleep.
详细描述
The overall goal of this study is to determine feasibility of a tart cherry juice intervention in older adults, and generate preliminary data of outcomes and mechanisms related to sleep. We propose a 2-arm randomized, double-blind, cross-over study in 20 older adults with self-reported insomnia. Participants will consume 240 mL of tart cherry juice or placebo (calorically matched to the tart cherry juice beverage, but theoretically devoid of melatonin, tryptophan, magnesium and flavonoids), twice/evening for 4 weeks in a randomly assigned order.
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, Investigator, Outcomes Assessor)
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
- •Men and women aged ≥65 years
- •Self-reporting insomnia (e.g., trouble sleeping approximately 3 nights a week for at least 6 months and/or an Insomnia Severity Index score ≥ 10 points)
- •Usual bed-time between 8:00 pm and 1:00 am
排除标准
- •Unwilling to follow the study protocol
- •Inability to properly use the wearable device, complete smartphone-based surveys, or follow the intervention protocol
- •Self-report of medically diagnosed sleep disorders except insomnia (e.g., sleep apnea)
- •Current and consistent use of sleep aids or hypnotic prescriptions (e.g., trazadone)
- •Self-report of cognitive impairment, dementia, or other neurological disorder
- •Are on unstable medications (i.e., change within the last 3 months) for other conditions
- •Have an allergy to the intervention products
- •Self-report history of diabetes
- •Current alcohol (Alcohol Use Disorders Identification Test ≥4 points33,34) or drug use disorder (Drug Abuse Screening Test,35,36 DAST-10>2 points)
- •Are excessive caffeine drinkers (>5 cups of caffeinated beverages a day)
- •Any other reason/condition the PI and investigative team believe this intervention would be unsafe
研究组 & 干预措施
Placebo Juice
干预措施: Placebo juice (Other)
Tart Cherry Juice
干预措施: Tart Cherry Juice (Other)
结局指标
主要结局
Recruitment Rate
时间窗: From first contact until randomization
Number of individuals that need to be screened to be enrolled that are randomized to the intervention.
Attrition
时间窗: From randomization until end of 12 week study
Number of individuals randomized that withdraw from the intervention after randomization and starting the intervention product.
Compliance
时间窗: From randomization until end of 12 week study
The number of doses consumed/ the number of intended doses (%)
Ability to Collect Data
时间窗: From enrollment to end of 12 week study
The percentage of missing data points from electronic capture data devices.
Practicality
时间窗: Week 12 study visit
Self-reported willingness to continue the dietary regimen after study completion.
次要结局
- Sleep Quantity (minutes)(From enrollment to end of 12 week study)
- Sleep Quality(Week 1, Week 5, Week 8, Week 12)
- Urinary melatonin metabolite (6-sulphatoxymelatonin)(Week 1, Week 5, Week 8, Week 12)
- Serum Marker of Serotonin (kynurenine/tryptophan ratio in blood)(Week 1, Week 5, Week 8, Week 12)
- Urinary Cortisol(Week 1, Week 5, Week 8, Week 12)
- Interleukin 6 in blood(Week 1, Week 5, Week 8, Week 12)
- C-reactive Protein in Blood(Week 1, Week 5, Week 8, Week 12)
研究者
Courtney Millar
Assistant Scientist II
Hebrew SeniorLife