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

Not Applicable

Completed

• Conditions: Postmenopause
• Interventions: Dietary Supplement: High daidzein supplement; Dietary Supplement: High genistein supplement

• Registration Number: NCT01556737
• Lead Sponsor: Wageningen University

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).

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-30
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplement	High daidzein supplement	-
Supplement	High genistein supplement	-
Placebo	High daidzein supplement	-
Placebo	High genistein supplement	-

Primary Outcome Measures

Name	Time	Method
Gene-expression in PBMCs	after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo	after placebo vs after treatment measured by microarrays

Secondary Outcome Measures

Name	Time	Method
Isoflavone levels in plasma	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
Gene - expression in adipose tissue	after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo	after placebo vs after treatment measured by QPCR
Isoflavone levels in adipose tissue	after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo	levels after placebo vs levels after treatment measured by HPLC

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Gelderland, Netherlands