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Effects of two different isoflavone supplement preparations on gene-expression in postmenopausal women

Effects of two different isoflavone supplement preparations on gene-expression in postmenopausal women - ISO II study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35572
Enrollment
72
Registered
2011-11-21
Start date
2012-02-07
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen specifieke aandoening door het gebruik van microarrays nvt

Interventions

Two intervention periods of eight weeks with an one of the two isoflavone supplements and a placebo for each subject and a washout period of 8 weeks in between.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: women 50-70 year postmenopausal

Exclusion criteria

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 in medical history - alcohol and drug abuse - current smoker - BMI >35 kg/m2 - allergy to soy (products)

Design outcomes

Primary

MeasureTime frame
The main study parameter is gene-expresion in PBMCs measured by micro-arrays

Secondary

MeasureTime frame
Isoflavone levels in plasma Gene - expression measured by micro-arrays in adipose tissue Isoflavone levels in adipose tissue.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)