NCT06715475进行中（未招募）不适用
A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Number of individuals who experienced adverse events
研究概览
简要总结
This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep.
详细描述
In this study, the investigators will confirm the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The investigators will also exploratory assess blood plasmalogen levels and the effect of plasmalogen-containing food on sleep conditions. The groups to be compared are plasmalogen-containing food and a placebo (plasmalogen-free food).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Healthy individuals
排除标准
- •Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
- •Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
- •Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- •Individuals who are undergoing medical treatment or have a medical history for any of the following diseases: mental disorder (such as depression), sleep apnea syndrome, hypersomnia, narcolepsy, insomnia, or valvular heart disease
- •Individuals who have habits of consuming foods or using devices to improve sleep
- •Individuals who have irregular sleeping habits due to lifestyle such as night shifts
- •Individuals who fall under the following sleeping conditions: sleeping in the same room with two or more people, living with preschool-aged children, living with individuals who require nursing care, or having their sleep potentially disturbed by the influence of others
- •Individuals who have nocturia two times or more
- •Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
- •Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
- •Individuals who are taking medications (including herbal medicines) or supplements
- •Individuals who are allergic to medicines or foods related to the test product
- •Individuals who are pregnant, lactating, or planning to become pregnant during this study
- •Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
- •Individuals who are judged as ineligible to participate in this study by the physician
结局指标
主要结局
Number of individuals who experienced adverse events
时间窗: Intervention period (up to 12 weeks)
An adverse event is defined as the "development of a new abnormality" or "worsening" in physical signs, symptoms, etc. that is clinically meaningful to the study participant during the study period, and the investigator will evaluate the relationship between the adverse event and the test product.
次要结局
- Number of individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at Baseline (before intervention)(Week 6 and Week 12)
- The measured values of blood plasmalogen levels at Week 6 and Week 12(Week 6 and Week 12)
- The changes from baseline of blood plasmalogen levels at Week 6 and Week 12(Baseline, Week 6, and Week 12)
- Each questionnaire item in the St. Mary's Hospital Sleep Questionnaire (SMH) at Week 6 and Week 12(Week 6 and Week 12)
研究者
研究点 (4)
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