Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Gene-expression in PBMCs
研究概览
简要总结
Alleged benefits experienced after the consumption of soy in Asian countries have been attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are believed to relieve menopausal symptoms and are therefore often consumed in supplement form in Western countries. These supplements contain relatively high amounts of isoflavones and are on the market in different compositions. The question is whether supplements with different compositions exert similar effects or whether the effects differ substantially.
详细描述
Intervention study with two substudies; each substudy is a double blind placebo controlled crossover intervention study. The first substudy has two groups: 'high daidzein' supplement versus placebo (n=18) and vice versa (n=18); the second substudy also has two groups 'high genistein' versus placebo (n=18) and vice versa (n=18).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •50-70 years
- •menstrual cycle absent for more than 1 year
排除标准
- •current use of contraceptives containing hormones
- •current use of hormone replacement therapy
- •regular soy product use (more than once a week)
- •regular isoflavone supplement use (more than once a week)
- •current use of medication containing sexhormones or sexhormone-triggering compounds
- •current use of anti-inflammatory medicines
- •use of antibiotics in the past 3 months
- •severe heart disease
- •thyroid disorders --> use of medicines for thyroid disorders
- •removed thyroid gland
- •complete ovarectomy
- •prior diagnosis of cancer
- •alcohol and drug abuse
- •current smoker
- •BMI >35 kg/m2
- •allergy to soy (products)
研究组 & 干预措施
Supplement
干预措施: High daidzein supplement (Dietary Supplement)
Supplement
干预措施: High genistein supplement (Dietary Supplement)
Placebo
干预措施: High daidzein supplement (Dietary Supplement)
Placebo
干预措施: High genistein supplement (Dietary Supplement)
结局指标
主要结局
Gene-expression in PBMCs
时间窗: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
after placebo vs after treatment measured by microarrays
次要结局
- Isoflavone levels in plasma(before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo)
- Gene - expression in adipose tissue(after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo)
- Isoflavone levels in adipose tissue(after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo)
研究者
Lisette de Groot
(Vera van der Velpen)
Wageningen University