JPRN-UMIN000041472已完成未知
Effects of lactic acid bacteria intake on perimenopausal men and women on menopause-like symptoms, sleep and biomarkers - Effects of lactic acid bacteria intake on perimenopausal men and women on menopause-like symptoms, sleep and biomarkers
TTC Co., Ltd0 个研究点目标入组 80 人开始时间: 2021年12月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Subjects who have passed more than one year after menopause (2) Subjects with history, treatment history, medication, or health food intake affecting the assessment of climacteric symptoms (3) Subjects with history, treatment history, medication, or health food consumption that affect sleep assessment (4) Subjects who ingest excessively soy products such as natto and soy drinks (5) Subjects who take foods rich in lactic acid bacteria (yogurt, lactic acid bacteria beverages, etc.) at least three times a week (6) Subjects who have had ovarian, uterine or orchiectomy surgery (7) Excessive smokers, alcohol addicts, and subjects with extremely irregular diets (8) Subjects whose overall score of the Pittsburgh Sleep Questionnaire at the pre-examination is less than 3, or more than 10, or who are estimated to have sleep disorders such as insomnia from the answers (9) Subjects whose BMI are 30.0 kg/m^2 or more (10) Subjects who are awakened midway through external factors such as child crying at least twice a week (11) Night and day shift worker or manual laborer (12) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion (13) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14) Subjects considered unsuitable as subjects based on pre-examination laboratory test values, measurement values, and prostate tumor markers (15) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (16) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study (17) Subjects who are judged as unsuitable for the study by investigator for other reasons
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