Postmenopause
Conditions
Keywords
isoflavone, supplement, daidzein, genistein, gene expression
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTHigh daidzein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
DIETARY_SUPPLEMENTHigh genistein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
Sponsors
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * 50-70 years * menstrual cycle absent for more than 1 year
Exclusion criteria
* 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 * diabetes * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene-expression in PBMCs | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | after placebo vs after treatment measured by microarrays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Isoflavone levels in plasma | before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo | after placebo vs after treatment measured by HPLC |
| Gene - expression in adipose tissue | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | after placebo vs after treatment measured by QPCR |
| Isoflavone levels in adipose tissue | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | levels after placebo vs levels after treatment measured by HPLC |
Countries
Netherlands
Outcome results
None listed