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

Postmenopause Clinical Trial

— ISOII  

Official title:

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

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

• Postmenopause

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