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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01556737
Other study ID # NL37475.081.11
Secondary ID ISO II study
Status Completed
Phase N/A
First received January 9, 2012
Last updated October 30, 2012
Start date November 2011
Est. completion date September 2012

Study information

Verified date October 2012
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High daidzein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
High genistein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones

Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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