Evaluation of a Lavender-based Natural Product System for Sleep Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Uric acid (mg/dL)
研究概览
简要总结
The goal of this clinical trial is to learn whether lavender essential oil-based product system can affect gene expression, serum protein markers, and sleep quality in healthy volunteers. The main questions this study aims to answer are:
- Does the lavender essential oil-based product system affect gene expression and protein markers as measured in blood?
- Does the lavender essential oil-based product system affect subjective quality of life and sleep assessments?
- Is daily use of the product system safe, as measured by laboratory tests and adverse events?
The lavender essential oil-based product system contains three components: an essential oil blend, a topical stick, and a dietary supplement.
Participants will:
- Receive a fitness tracker to monitor their sleep and physical activity.
- Use the lavender essential oil-based product system for six weeks total according to this schedule:
- 1 week: Essential oil blend
- 1 week: Essential oil blend + topical stick
- 4 weeks: Essential oil blend + topical stick + dietary supplement
- Attend two study visits in which they provide blood and urine samples, and complete subjective sleep and quality of life assessments
- Complete weekly subjective sleep assessments from home
详细描述
This single-blind study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of sleep system products for 6 weeks. Quality of life and sleep quality will be assessed using subjective surveys and questionnaires. Safety markers (liver and kidney function, hematology, urinalysis, and adverse events) will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The study includes a single arm. Participants did not know the market name of the products they used. Products were packaged in plain bottles with the instruction label affixed.
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 35-50 years old
- •Non-smokers
- •Local to Pleasant Grove, Utah, and/or willing to come to clinical research center for study visits
- •Willing and able to apply study products internally, topically and aromatically for about 6 weeks
- •Willing to track use of study product on paper forms, via survey, or other means
- •Willing to washout from all over-the-counter sleep aids, internally-consumed essential oils, alcohol, and lavender-based products for approximately 7 weeks
- •Taking <100 mg caffeine daily, and willing to avoid consumption of caffeine after 3pm
- •Not working night shift or swing shift
- •Not consistently traveling to other time zones (or willing to arrange schedule to avoid during study)
- •No known medical condition or sensitivity which would make the application of these study products unsafe
- •Own a smart device that can download and run the accelerometer application
- •Willing and able to keep the same sleeping arrangements as much as possible throughout the study
- •Willing to receive and respond to regular texts, emails, and/or phone calls from study staff
- •No pregnancy within the last 60 days or currently breastfeeding (females)
- •Not currently or previously participating in any other clinical trial within the last 30 calendar days
- •Signed informed consent, HIPAA Authorization, and Confidentiality Agreement
- •No major medical conditions (especially cardiac, lung, metabolic, cancer, or sleep) under the active care of a doctor
- •No prescription medications that may interfere with sleep (e.g. attention deficit hyperactivity disorder stimulants, antihistamines, psychiatric drugs, sleep medications, narcotics, etc.)
- •No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical reviewer, put the participant at risk or affect study results, procedures, or outcomes (e.g. obstructive sleep apnea, morbid obesity, cardiometabolic disease, cancer, lung-related conditions)
- •Willing and able (in the opinion of the investigator) to comply with all study requirements and procedures
排除标准
- •Failure to meet any of the above inclusion criteria
结局指标
主要结局
Uric acid (mg/dL)
时间窗: 6 weeks
Serum marker for inflammation and signal of developing various disease processes
Gene expression
时间窗: 6 weeks
Gene expression analysis refers to a genome-wide quantification of methylation. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another.
Cortisol (ug/mL)
时间窗: 6 weeks
Serum marker for stress response
Minutes asleep
时间窗: 6 weeks
Mean nightly minutes asleep determined by fitness tracker
Number of awakenings
时间窗: 6 weeks
Mean nightly number of awakenings determined by fitness tracker
Rapid Eye Movement (REM) sleep (minutes)
时间窗: 6 weeks
Mean nightly minutes of REM sleep determined by fitness tracker
Interleukin 6 (pg/mL)
时间窗: 6 weeks
Serum marker for inflammation
C-reactive protein (mg/L)
时间窗: 6 weeks
Serum marker for inflammation
Minutes awake
时间窗: 6 weeks
Mean nightly minutes awake determined by fitness tracker
Light sleep (minutes)
时间窗: 6 weeks
Mean nightly minutes of light sleep determined by fitness tracker
Deep sleep (minutes)
时间窗: 6 weeks
Mean nightly minutes of deep sleep determined by fitness tracker
次要结局
- Alkaline phosphatase (U/L)(6 weeks)
- Blood urea nitrogen (BUN) (mg/dL)(6 weeks)
- Chloride (mmol/L)(6 weeks)
- Short Form-20 (SF-20) scale(6 weeks)
- Alanine transaminase (ALT) (U/L)(6 weeks)
- Creatinine (mg/dL)(6 weeks)
- Sodium (mmol/L)(6 weeks)
- Leeds Sleep Evaluation Questionnaire (LSEQ)(6 weeks)
- Carbon Dioxide (mmol/L)(6 weeks)
- Total bilirubin (mg/dL)(6 weeks)
- Albumin (g/dL)(6 weeks)
- Total protein (g/dL)(6 weeks)
- Safety/tolerability(6 weeks)
- Potassium (mmol/L)(6 weeks)
- Aspartate aminotransferase (AST) (U/L)(6 weeks)
- Calcium (mg/dL)(6 weeks)
- Functional Outcomes of Sleep Questionnaire (FOSQ)(6 weeks)