The Effect of Isoflavone Supplement Intake on Gene-expression in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gene-expression measured by micro-arrays
研究概览
简要总结
Alleged benefits experienced by 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 the question is if these concentrations still exert beneficial effects or whether negative effects become dominant. Therefore, the investigators will study the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.
详细描述
Primary Objective: to determine the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.
Secondary Objectives: to determine the association between isoflavone plasma levels and gene-expression in PBMCs; to determine the variation of isoflavone plasma levels between subjects after intake of isoflavones for four and eight weeks; to explore whether PBMC gene-expression markers identified after 8 weeks isoflavone intervention are already present after 4 weeks intervention; to explore whether the severity of previous menopausal complaints is related to the effect of isoflavones on PBMC gene-expression; and to explore the association between isoflavone levels in plasma and spot urine.
Study design: Double-blind placebo controlled crossover intervention study
Study population: Thirty-six healthy females, 45-70 years, post-menopausal and equol-producing
Intervention: Two intervention periods of eight weeks with a isoflavone supplement or a placebo and a washout period of 8 weeks in between.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45-70 years
- •Equol producer
- •Post-menopausal (Follicle Stimulating Hormone (FSH) >40 UI/L) or
- •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 sex hormones or sex hormone-triggering compounds
- •current use of anti-inflammatory medicines
- •use of antibiotics in the past 6 months
- •severe heart disease
- •thyroid disorders
- •removed thyroid gland
- •complete ovariectomy
- •prior diagnosis of cancer in medical history
- •alcohol and drug abuse
- •current smoker
- •Body Mass Index (BMI) >35 kg/m2
- •allergy to soy (products)
结局指标
主要结局
Gene-expression measured by micro-arrays
时间窗: after 8 weeks of exposure to the placebo
Gene expression changes will be assessed in PBMCs using whole genome Affymetrix microarrays. The gene expression changes after exposure to the isoflavone supplement will be compared to the changes after exposure to the placebo.
次要结局
- Isoflavone levels in plasma and spoturine(after 8 weeks of exposure to the placebo)
- Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)(after 8 weeks of exposure to the placebo)
研究者
Lisette de Groot
(Vera van der Velpen)
Wageningen University