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OpenTrials
Completed

NCT Number: NCT01556737

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.

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Key information

Conditions

Postmenopause

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High daidzein supplement

Dietary Supplement

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

Other names: Phyto soya forte - Arkpharma

High genistein supplement

Dietary Supplement

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

Other names: Mega Soja - Springfield

Primary outcomes

  1. 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

  1. Isoflavone levels in plasma

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

    after placebo vs after treatment measured by HPLC

  2. Gene - expression in adipose tissue

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

    after placebo vs after treatment measured by QPCR

  3. Isoflavone levels in adipose tissue

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

    levels after placebo vs levels after treatment measured by HPLC

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Acronym: ISOII

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2012
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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