A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Urine Equol Concentration
研究概览
简要总结
The main aim of this study is to evaluate the effect of equol on menopausal symptoms of women. Our hypothesis is that equol producers will have milder menopausal symptoms compared to non-equol producers. Equol is known as a metabolite produced by gut microbiota from soy-related diet and has estrogen-like activity compared to the isoflavones from soybean.
Previous studies have shown that some women can produce equol from soy-related diet, but the others cannot because they don't have the bacteria which can metabolite daidzein in gut even if they take isoflavones thorough soybean products.
This study will involve participants consuming a soy protein bar and collection of urine samples before and after its consumption.
详细描述
Day 0 - Recruitment and consent taking. Height, weight and blood pressure would be measured. Patients will also fill up questionnaires on basic demographics, menopausal symptoms (Menopause Rating Scale and Vulvovaginal Symptom Questionnaire), Food Frequency Questionnaire for Soy intake, International Physical Activity Questionnaire.
Day 1 - Collect first morning urine between 5ml to 10 ml in the pre-labelled (will not contain identifiers but only assigned study subject number) containers provided. Store the urine sample in cool place in room temperature and dispatch to site after the second sample has been collected. To consume a soy based protein bar provided by study after dinner on day 1.
Day 2 - Collect first morning urine between 5ml to 10 ml in the pre-labelled(will not contain identifiers but only assigned study subject number) containers provided. Double bag the containers and call courier to dispatch urine to KK Women's and Children's Hospital.
All urine samples received will be immediately frozen and stored in KKH in a freezer. The samples will be couriered to Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co. Ltd, Japan in batches for analysis of urinary equol concentration. Clinical Trials Agreement has been executed between Otsuka Pharmaceutical Co. Ltd, Japan and KK Women's and Children's Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 40-60
排除标准
- •Pregnant women
- •Allergy to Soy
- •Allergy to nuts
- •Consumed antibiotics within 7 days of the study
- •Has a history of autoimmune diseases
- •Has a history of thyroid disease
- •On medical treatment with hormone therapy, elective oestrogen receptors modulators
- •Consuming equol-containing supplements or food
- •Consuming painkillers
- •Consuming anti-depressants and/or sleeping pills
结局指标
主要结局
Urine Equol Concentration
时间窗: first morning urine sample collected at baseline and first urine sample collected the morning after consuming the soy bar
Equol is a metabolite of isoflavone which is secreted in the urine
次要结局
未报告次要终点
研究者
Ang Seng Bin
Senior Consultant
KK Women's and Children's Hospital