Clinical trial NCT01556737: Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
Official title: Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopause
Keywords: isoflavone
supplement
daidzein
genistein
gene expression
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 72
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Gene-expression in PBMCs
timeFrame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
Secondary outcomes:
measure: Isoflavone levels in plasma
timeFrame: before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo
measure: Gene - expression in adipose tissue
timeFrame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
measure: Isoflavone levels in adipose tissue
timeFrame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Pieter van 't Veer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Velpen V, Geelen A, Hollman PC, Schouten EG, van 't Veer P, Afman LA. Isoflavone supplement composition and equol producer status affect gene expression in adipose tissue: a double-blind, randomized, placebo-controlled crossover trial in postmenopausal women. Am J Clin Nutr. 2014 Nov;100(5):1269-77. doi: 10.3945/ajcn.114.088484. Epub 2014 Aug 20.