NCT04988542Unknown不适用
Clinical Efficacy of a Novel Delivery Supplement on Sleep Quality
TruDiagnostic0 个研究点目标入组 30 人开始时间: 2021年8月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Epigenetic Age
研究概览
简要总结
This is a prospective randomized clinical study of 30 patients to evaluate a novel sleep supplement. This study will be evaluating the effectiveness of the supplement over a 2 month program. The study will assess the effects that the supplement has on a patient's sleep metrics and epigenetic age biomarkers.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women of any ethnicity.
- •Age Range - 16 - 65
- •Patient must be able to comply with treatment plan and laboratory tests
排除标准
- •Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- •No immune system issues or immunodeficiency disease
- •No history of viral illness which could be reactivated by immune downregulation
- •Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
- •Diagnosis of a transient ischemic attack in the 6 months prior to screening
- •Patients infected with hepatitis, C or HIV
- •Patients with Body Mass Index (BMI) > 40 kg/m2
- •Presence of active infection
- •Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
- •Unable or unwilling to provide required blood sample for testing
- •As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
- •If the patient has previously used any products in a month prior to the start of the trial.
- •Known sleep disorder ie. obstructive sleep apnea
- •Presence of schizophrenia, bipolar disorder
- •Concurrent use of cannabis
研究组 & 干预措施
Sleep supplement
Experimental
Circadian Wellness sleep SL strip nightly for 30 days.
干预措施: Circadian Wellness sleep SL strip (Dietary Supplement)
Control Group
Placebo Comparator
Participants in the control group will have no intervention and no change in their usual daily routine or supplements. They will be asked to not take any sleep aid supplement during the study period.
干预措施: Circadian Wellness sleep SL strip (Dietary Supplement)
结局指标
主要结局
Epigenetic Age
时间窗: Change from baseline to 2 months
次要结局
- Sleep duration(change from baseline to 2 months)
研究者
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