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CompletedNCT01556737ISOIIUpdated Oct 31, 2012

Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women

An interventional study of High daidzein supplement and High genistein supplement in Postmenopause, sponsored by Wageningen University. Completed at 1 site in Netherlands. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-31.

Sponsored by Wageningen University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Postmenopause

Keywords

  • isoflavone
  • supplement
  • daidzein
  • genistein
  • gene expression
03

In context

Lead sponsor

Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female
  • 50-70 years
  • menstrual cycle absent for more than 1 year

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Supplement

    Dietary Supplement: High daidzein supplement · Dietary Supplement: High genistein supplement

  • Placebo comparator
    Placebo

    Dietary Supplement: High daidzein supplement · Dietary Supplement: High genistein supplement

Interventions

  • Dietary supplementHigh daidzein supplement

    8 weeks exposure to the supplement, daily 100 mg of isoflavones

    Also known as: Phyto soya forte - Arkpharma

  • Dietary supplementHigh genistein supplement

    8 weeks exposure to the supplement, daily 100 mg of isoflavones

    Also known as: Mega Soja - Springfield

06

What researchers measure

Primary outcomes

  1. Gene-expression in PBMCs

    after placebo vs after treatment measured by microarrays

    Time frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo

Secondary outcomes

  1. Isoflavone levels in plasma

    after placebo vs after treatment measured by HPLC

    Time frame: before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo

  2. Gene - expression in adipose tissue

    after placebo vs after treatment measured by QPCR

    Time frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo

  3. Isoflavone levels in adipose tissue

    levels after placebo vs levels after treatment measured by HPLC

    Time frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo

07

Study locations

1 site
  • Wageningen University
    Wageningen, Gelderland 6700 EV, Netherlands
08

References and documents

Publications

  • 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. PubMed 25332325 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01556737
Lead sponsor
Wageningen University
Responsible party
Lisette de Groot ((Vera van der Velpen), Wageningen University) — Principal investigator
First posted
Mar 16, 2012
Start date
Nov 2011
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Oct 31, 2012

Study contacts

Pieter van 't Veer, Prof
principal investigator · Wageningen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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