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The effect of isoflavone supplement intake on gene-expression in postmenopausal women

The effect of isoflavone supplement intake on gene-expression in postmenopausal women - ISO study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34551
Enrollment
36
Registered
2010-08-20
Start date
2010-10-25
Completion date
Unknown
Last updated
2024-05-06

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 micro-arrays nvt

Interventions

Two intervention periods of eight weeks with a isoflavone supplement or a placebo 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 45-70 year post-menopausal equol-producing

Exclusion criteria

Exclusion criteria: current use of contraceptives containing hormones current use of hormone replacement therapy current soy product use (more than once a week) current isoflavone supplement use (more than once a week) current use of medication containing sexhormones or sexhormone-triggering compounds current use of anti-inflammatory drugs use of antibiotics in the past 6 months severe heart disease thyroid disorders complete ovarectomy thyroidectomy prior diagnosis of cancer in medical history Alcohol and drug abuse Current smoking habits BMI >35 kg/m2 allergic to soy (products)

Design outcomes

Primary

MeasureTime frame
The main study parameter is gene-expression measured by micro-arrays.

Secondary

MeasureTime frame
Isoflavone levels in plasma and in spoturine

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)