NCT01399216已完成不适用
Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Basal body temperature
研究概览
简要总结
We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in subjects with low basal body temperature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women with basal body temperature < 36.0 ºC
- •Healthy as based on medical history and physical examination
- •Willing not to donate blood during the study
- •Informed consent signed
排除标准
- •Renal or hepatic dysfunction
- •Heart disease
- •Participation in any clinical trial within 90 days of the commencement of the trial
- •Subjects who are taking medicines or functional food that may affect basal body temperature
研究组 & 干预措施
Fucoidan supplement
Experimental
干预措施: Supplement containing fucoidan, EPA, and DHA (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Basal body temperature
时间窗: up to 20 weeks
次要结局
- Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)(Weeks 0, 8, 12, and 20)
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University
研究点 (1)
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