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| ID | Type | Description | Link |
|---|---|---|---|
| ISO II study | Other Identifier | Wageningen University |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High daidzein supplement | Dietary Supplement | 8 weeks exposure to the supplement, daily 100 mg of isoflavones |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Isoflavone levels in plasma | after placebo vs after treatment measured by HPLC | before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo |
| Gene - expression in adipose tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter van 't Veer, Prof | Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University | Wageningen | Gelderland | 6700 EV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25332325 | Derived | 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. |
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| High genistein supplement | Dietary Supplement | 8 weeks exposure to the supplement, daily 100 mg of isoflavones |
|
|
after placebo vs after treatment measured by QPCR
| after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo |
| Isoflavone levels in adipose tissue | levels after placebo vs levels after treatment measured by HPLC | after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo |