NCT05368909已完成不适用
Assessment of the Effects of a Dietary Supplement on the Sleep Health and Sleep Quality of People With Sleep Problems: A Randomized, Double-blind, Placebo-controlled, Crossover Design Study
4Life Research, LLC2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Saliva Melatonin level changes
研究概览
简要总结
The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers
- •Judged by the Investigator to be in general good health on the basis of medical history
- •Willing to wash out of all dietary supplements, essential oils, and non-prescription sleep aids or Rx sleep aids for the duration of the study
- •Insomnia Severity Index score of ≥ 8
- •Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
排除标准
- •Pregnant and/or lactating women
- •Known allergy or adverse reaction to ingredients in the product: Tri Factor (bovine colostrum and egg yolk extracts), Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) or Magnesium
- •Prescription sedative or psychoactive (including anti-depressant) medication use
- •Diagnosis of a sleep disorder (e.g., sleep apnea, periodic limb movement disorder, etc.) or high clinical probability of another sleep disorder based on sleep history
- •A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 4 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
- •Routine consumption of more than 2 alcoholic beverages per day or consumption of caffeine past 2 PM for the duration of the study
- •Illicit drug use
- •Use of prescription stimulants (modafinil, dextroamphetamine, etc.)
- •Use of prescription medications known to affect sleep (antidepressants, anti-anxiety, opioids, alpha-blockers, beta-blockers, corticosteroids, ACE inhibitors, angiotensin II-receptor blockers, cholinesterase inhibitors, allergy medication, asthma medication, glucosamine and chondroitin, statins, anti-smoking or thyroid medication, muscle relaxants, anticonvulsants)
- •Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 10th grade reading level; visual, hearing or upper extremity motor deficit
- •Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months
- •Unwilling to consume or unable to swallow capsules/tablets
- •Previous exposure to this product in earlier testing phases
结局指标
主要结局
Saliva Melatonin level changes
时间窗: 6 weeks
Samples taken before bedtime at night and 2 hours after wakeup the next morning. A total of 8 samples were taken for each subject: (2) right after first washout, (2) right after Arm 1, (2) right after the second washout, (2) right after Arm 2.
Insomnia Severity Index Score
时间窗: 6 weeks
A scale used to measure the severity of insomnia. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
次要结局
- Sleep Onset Latency(6 weeks)
- Total Sleep Time(6 weeks)
- Leeds Sleep Evaluation Questionnaire (LSEQ) Score(6 weeks)
- Sleep Efficiency(6 weeks)
研究者
研究点 (2)
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