Eat Walnuts and Sleep Better: Exploring the Potential Role of Walnuts as Sleep-promoting Food and Their Impact on Body Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in sleep onset latency from baseline to weeks 4, 8, 14, and 18
研究概览
简要总结
Walnuts have a unique nutritional profile, including the sleep-regulating hormone melatonin, tryptophan, and omega-3 fatty acids, the two latest nutrients involved in melatonin and serotonin synthesis. Although it has been claimed that walnuts may improve sleep, to the investigators' knowledge, no studies have been conducted to objectively determine the impact of walnut consumption on sleep and overall well-being. Therefore, this study aims to investigate the effect of daily walnut consumption on sleep parameters (such as quality and duration). Secondarily, it aims to investigate the impact of daily walnut consumption on body composition, eating behavior, and well-being.
详细描述
The study to investigate the effect of daily walnut consumption on sleep quality will be conducted in an 18-week randomized crossover trial, in which participants will be initially assigned to intervention or control conditions for 8-weeks. After 2 weeks of washout, subjects will be crossed over to the alternate intervention and will continue for another 8 weeks. Note that throughout the whole study, each participant will attend 5 visits: 1 initial visit (baseline) and 2 visits in each one of the study conditions (intervention and control).
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 19-26 kg/m^2
- •Habitual moderate exercise level
- •No recent history of weight change exceeding 2.3kg (5lb) within the prior 3 months.
排除标准
- •Nuts allergy
- •Any acute or chronic diseases
- •Any drugs or supplementations
- •Any alimentary restrictions or specific diets
- •Being a shift or night workers
- •Being unable to give written informed consent.
结局指标
主要结局
Changes in sleep onset latency from baseline to weeks 4, 8, 14, and 18
时间窗: Weeks 4, 8, 14 and 18
Measured in hours of sleep with an actigraph (ActTrust, CONDOR, Brazil)
Changes in sleep efficiency from baseline to weeks 4, 8, 14, and 18
时间窗: Weeks 4, 8, 14 and 18
Calculated in percentage as the ratio of total sleep time (TST) to time in bed (TIB). Sleep efficiency (percent) = (TST/TIB)\*100
Changes in wake after sleep onset (WASO) from baseline to weeks 4, 8, 14, and 18
时间窗: Week 4, 8, 14, and 18
Measured in minutes of WASO with an actigraph (ActTrust, CONDOR, Brazil)
Changes in sleep duration from baseline to weeks 4, 8, 14, and 18
时间窗: Weeks 4, 8, 14, and 18
Measured in hours of sleep time with an actigraph (ActTrust, CONDOR, Brazil)
Changes in urinary 6-sulphaoxymelatonin from baseline to week 4, 8, 14 and 18
时间窗: Week 4, 8, 14 and 18
Quantified using urine Melatonin-Sulfate ELISA kit
次要结局
- Changes in body fat from baseline to weeks 4, 8, 14, and 18(Weeks 4, 8, 14 and 18)
- Changes in well-being from baseline to weeks 8 and 18(Weeks 8 and 18)
- Changes in body mass index (BMI) from baseline to weeks 4, 8, 14, and 18(Weeks 4, 8, 14 and 18)
- Changes in weight circumference from baseline to weeks 4, 8, 14, and 18(Weeks 4, 8, 14 and 18)
- Changes in eating behavior from baseline to weeks 8 and 18(Weeks 8 and 18)
研究者
Dra. Maria Izquierdo-Pulido
Full Professor
University of Barcelona