Postmenopause Clinical Trial
— ISOIIOfficial title:
Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gene-expression in PBMCs | after placebo vs after treatment measured by microarrays | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | No |
Secondary | Isoflavone levels in plasma | after placebo vs after treatment measured by HPLC | before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo | No |
Secondary | Gene - expression in adipose tissue | after placebo vs after treatment measured by QPCR | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | No |
Secondary | Isoflavone levels in adipose tissue | levels after placebo vs levels after treatment measured by HPLC | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | No |
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