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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopause
• Intervention / Treatment: Dietary supplement: High daidzein supplement; Dietary supplement: High genistein supplement

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6700 EV
      • Wageningen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wageningen University
• Investigators: Principal Investigator: Pieter van 't Veer, Prof, Wageningen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (Estimate): March 16, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 30, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: supplement; gene expression; genistein; isoflavone; daidzein
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Estrogens, Non-Steroidal; Estrogens; Protein Kinase Inhibitors; Anticarcinogenic Agents; Phytoestrogens; Genistein; Daidzein
• Other Study ID Numbers: NL37475.081.11; ISO II study (Other Identifier: Wageningen University)