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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Postmenopause

Intervention / Treatment
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* Dietary Supplement: High daidzein supplement
* Dietary Supplement: High genistein supplement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement<br> | Dietary Supplement: High daidzein supplement<br>* 8 weeks exposure to the supplement, daily 100 mg of isoflavones<br>* Other names: Phyto soya forte - Arkpharma;Dietary Supplement: High genistein supplement<br>* 8 weeks exposure to the supplement, daily 100 mg of isoflavones<br>* Other names: Mega Soja - Springfield;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: High daidzein supplement<br>* 8 weeks exposure to the supplement, daily 100 mg of isoflavones<br>* Other names: Phyto soya forte - Arkpharma;Dietary Supplement: High genistein supplement<br>* 8 weeks exposure to the supplement, daily 100 mg of isoflavones<br>* Other names: Mega Soja - Springfield;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene-expression in PBMCs | after placebo vs after treatment measured by microarrays | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isoflavone levels in plasma | after placebo vs after treatment measured by HPLC | before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo | 
| Gene - expression in adipose tissue | after placebo vs after treatment measured by QPCR | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | 
| Isoflavone levels in adipose tissue | levels after placebo vs levels after treatment measured by HPLC | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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isoflavone, supplement, daidzein, genistein, gene expression