NCT01232751

Brief Summary

Alleged benefits experienced by 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 the question is if these concentrations still exert beneficial effects or whether negative effects become dominant. Therefore, the investigators will study the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

October 21, 2010

Last Update Submit

January 9, 2012

Conditions

Postmenopause

Keywords

healthwomen

Outcome Measures

Primary Outcomes (2)

  • Gene-expression measured by micro-arrays

    Gene expression changes will be assessed in PBMCs using whole genome Affymetrix microarrays. The gene expression changes after exposure to the isoflavone supplement will be compared to the changes after exposure to the placebo.

    gene-expression after 8 weeks of exposure to the isoflavone supplement

  • Gene-expression measured by micro-arrays

    Gene expression changes will be assessed in PBMCs using whole genome Affymetrix microarrays. The gene expression changes after exposure to the isoflavone supplement will be compared to the changes after exposure to the placebo.

    after 8 weeks of exposure to the placebo

Secondary Outcomes (12)

  • Isoflavone levels in plasma and spoturine

    after 0 weeks of exposure to the isoflavone supplement

  • Isoflavone levels in plasma and spoturine

    after 4 weeks of exposure to the isoflavone supplement

  • Isoflavone levels in plasma and spoturine

    after 8 weeks of exposure to the isoflavone supplement

  • Isoflavone levels in plasma and spoturine

    after 0 weeks of exposure to the placebo

  • Isoflavone levels in plasma and spoturine

    after 4 weeks of exposure to the placebo

  • +7 more secondary outcomes

Interventions

Isoflavone supplementDIETARY_SUPPLEMENT

The participants will consume 2 times 2 supplements per day, which will lead to a daily dose of 114 mg. (HPLC analysis confirmed an aglycone isoflavone content of 28.41 mg per supplement)

Also known as: Phytosoya forte (35mg) from the company Arkopharma

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Equol producer
  • Post-menopausal (Follicle Stimulating Hormone (FSH) \>40 UI/L) or
  • menstrual cycle absent for more than 1 year.

You may not qualify if:

  • 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 sex hormones or sex hormone-triggering compounds
  • current use of anti-inflammatory medicines
  • use of antibiotics in the past 6 months
  • severe heart disease
  • thyroid disorders
  • removed thyroid gland
  • complete ovariectomy
  • prior diagnosis of cancer in medical history
  • alcohol and drug abuse
  • current smoker
  • Body Mass Index (BMI) \>35 kg/m2
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703 HD, Netherlands

Location

Related Publications (1)

  • van der Velpen V, Geelen A, Schouten EG, Hollman PC, Afman LA, van 't Veer P. Estrogen receptor-mediated effects of isoflavone supplementation were not observed in whole-genome gene expression profiles of peripheral blood mononuclear cells in postmenopausal, equol-producing women. J Nutr. 2013 Jun;143(6):774-80. doi: 10.3945/jn.113.174037. Epub 2013 Apr 24.

    PMID: 23616509DERIVED

Study Officials

  • Pieter van 't Veer, Professor

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
(Vera van der Velpen)

Study Record Dates

First Submitted

October 21, 2010

First Posted

November 2, 2010

Study Start

August 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations

NL(1)