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

NCT ID: NCT01556737

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

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).

Conditions

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Postmenopause

Keywords

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isoflavone supplement daidzein genistein gene expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Supplement

Group Type EXPERIMENTAL

High daidzein supplement

Intervention Type DIETARY_SUPPLEMENT

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

High genistein supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

High daidzein supplement

Intervention Type DIETARY_SUPPLEMENT

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

High genistein supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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High daidzein supplement

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

Intervention Type DIETARY_SUPPLEMENT

High genistein supplement

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Phyto soya forte - Arkpharma Mega Soja - Springfield

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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Lisette de Groot

(Vera van der Velpen)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pieter van 't Veer, Prof

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 25332325 (View on PubMed)

Other Identifiers

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ISO II study

Identifier Type: OTHER

Identifier Source: secondary_id

NL37475.081.11

Identifier Type: -

Identifier Source: org_study_id