NCT01232751

Effects of Isoflavones on Gene-expression

The Effect of Isoflavone Supplement Intake on Gene-expression in Postmenopausal Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Wageningen University · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Primary Objective: to determine 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. Secondary Objectives: to determine the association between isoflavone plasma levels and gene-expression in PBMCs; to determine the variation of isoflavone plasma levels between subjects after intake of isoflavones for four and eight weeks; to explore whether PBMC gene-expression markers identified after 8 weeks isoflavone intervention are already present after 4 weeks intervention; to explore whether the severity of previous menopausal complaints is related to the effect of isoflavones on PBMC gene-expression; and to explore the association between isoflavone levels in plasma and spot urine. Study design: Double-blind placebo controlled crossover intervention study Study population: Thirty-six healthy females, 45-70 years, post-menopausal and equol-producing Intervention: Two intervention periods of eight weeks with a isoflavone supplement or a placebo and a washout period of 8 weeks in between. Main study parameters/endpoints: The main study parameter is gene-expression in PBMCs measured by micro-arrays.

Conditions

• Postmenopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Isoflavone 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)

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-11-02
• Last updated: 2012-01-10

Locations

1 site across 1 country: Netherlands