Status:
COMPLETED
Effects of Isoflavones on Gene-expression
Lead Sponsor:
Wageningen University
Conditions:
Postmenopause
Eligibility:
FEMALE
45-70 years
Phase:
NA
Brief Summary
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 me...
Detailed Description
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-menopa...
Eligibility Criteria
Inclusion
- 45-70 years
- Equol producer
- Post-menopausal (Follicle Stimulating Hormone (FSH) \>40 UI/L) or
- menstrual cycle absent for more than 1 year.
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01232751
Start Date
August 1 2010
End Date
October 1 2011
Last Update
January 10 2012
Active Locations (1)
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1
Wageningen University
Wageningen, Gelderland, Netherlands, 6703 HD