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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
ClinicalTrials.gov Identifier:
NCT01556737
First received: January 9, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Postmenopause
 Dietary Supplement: High daidzein supplement
Dietary Supplement: High genistein supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Genistein
U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Gene-expression in PBMCs [ Time Frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo ] [ Designated as safety issue: No ]
    after placebo vs after treatment measured by microarrays


Secondary Outcome Measures:
  • Isoflavone levels in plasma [ Time Frame: before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo ] [ Designated as safety issue: No ]
    after placebo vs after treatment measured by HPLC

  • Gene - expression in adipose tissue [ Time Frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo ] [ Designated as safety issue: No ]
    after placebo vs after treatment measured by QPCR

  • Isoflavone levels in adipose tissue [ Time Frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo ] [ Designated as safety issue: No ]
    levels after placebo vs levels after treatment measured by HPLC


Enrollment: 72
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplement Dietary Supplement: High daidzein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
Other Name: Phyto soya forte - Arkpharma
Dietary Supplement: High genistein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
Other Name: Mega Soja - Springfield
Placebo Comparator: Placebo Dietary Supplement: High daidzein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
Other Name: Phyto soya forte - Arkpharma
Dietary Supplement: High genistein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
Other Name: Mega Soja - Springfield

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).

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556737

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
Wageningen University
Investigators
Principal Investigator: Pieter van 't Veer, Prof Wageningen University
  More Information

No publications provided

Responsible Party: Lisette de Groot, (Vera van der Velpen), Wageningen University
ClinicalTrials.gov Identifier: NCT01556737     History of Changes
Other Study ID Numbers: NL37475.081.11, ISO II study
Study First Received: January 9, 2012
Last Updated: October 30, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
isoflavone
supplement
daidzein
genistein
gene expression

Additional relevant MeSH terms:
Daidzein
Genistein
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013