Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wageningen University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Gene-expression in PBMCs
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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)
Arms & Interventions
Supplement
Intervention: High daidzein supplement (Dietary Supplement)
Supplement
Intervention: High genistein supplement (Dietary Supplement)
Placebo
Intervention: High daidzein supplement (Dietary Supplement)
Placebo
Intervention: High genistein supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Gene-expression in PBMCs
Time Frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
after placebo vs after treatment measured by microarrays
Secondary Outcomes
- 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)
Investigators
Lisette de Groot
(Vera van der Velpen)
Wageningen University