NCT01556737

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

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

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

January 9, 2012

Last Update Submit

October 30, 2012

Conditions

Postmenopause

Keywords

isoflavonesupplementdaidzeingenisteingene expression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Isoflavone levels in plasma

    before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo

  • Gene - expression in adipose tissue

    after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo

  • Isoflavone levels in adipose tissue

    after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo

Study Arms (2)

Supplement

EXPERIMENTAL
Dietary Supplement: High daidzein supplementDietary Supplement: High genistein supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: High daidzein supplementDietary Supplement: High genistein supplement

Interventions

High daidzein supplementDIETARY_SUPPLEMENT

8 weeks exposure to the supplement, daily 100 mg of isoflavones

Also known as: Phyto soya forte - Arkpharma
PlaceboSupplement
High genistein supplementDIETARY_SUPPLEMENT

8 weeks exposure to the supplement, daily 100 mg of isoflavones

Also known as: Mega Soja - Springfield
PlaceboSupplement

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • years
  • 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 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25332325DERIVED

Study Officials

  • Pieter van 't Veer, Prof

    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

January 9, 2012

First Posted

March 16, 2012

Study Start

November 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

NL(1)