A double blind placebo controlled parallel trial of soy isoflavones on markers of bone turnover in females in the early menopause

Hull and East Yorkshire Hospitals NHS Trust (UK)0 sites200 target enrollmentSeptember 5, 2012

Overview

Phase: 未知
Intervention: Not specified
Conditions: Effect of soy phyto-eastrogens to people during menopause as soy have been shown to improve menopausal flusing symptoms.
Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)
Enrollment: 200
Status: Completed
Last Updated: 7 years ago

Registry

who.int

Start Date

September 5, 2012

End Date

December 12, 2013

Last Updated

7 years ago

Study Type

Interventional

Sex

Female

Sponsor

Hull and East Yorkshire Hospitals NHS Trust (UK)

•1\. Women with a follicle\-stimulating hormone (FSH) and luteinizing hormone (LH) greater than 20 mU/L and amenorrhoea for 1 year with or without vasomotor instability of hot flushing will be eligible to participate
•2\. Caucasian women

•1\. Patients with liver dysfunction (ALT of greater than 135 u/L) or taking drugs that may interfere with liver function
•2\. Patients with impaired renal function (creatinine greater than 150, glomerular filtration rate less than 30\)
•3\. Patients who have had antibiotic treatment within the last 6 months will also be ineligible for the study as antibiotics are known to change gut microflora and thus will interfere with phytoestrogen metabolism. This will also mean that patients who start taking antibiotics during the study will have to be withdrawn
•4\. Patients not wishing to allow disclosure to their GPs
•5\. Patients on any medication within 3 months of the study including steroid inhalers or HRT
•6\. Patients already self\-supplementing with isoflavones
•7\. Vegetarian or vegans