Soy isoflavones on markers of bone turnover in females in the early menopause

Not Applicable

Completed

• Conditions: Effect of soy phyto-eastrogens to people during menopause as soy have been shown to improve menopausal flusing symptoms.; Nutritional, Metabolic, Endocrine; Menopausal and female climacteric states

• Registration Number: ISRCTN34051237
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29739677 2. 2018 results relating to thyroid hormone effects in https://www.ncbi.nlm.nih.gov/pubmed/30524380

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-05
• Study Completion: 2013-12-12
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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 This will also mean that patients who start taking antibiotics during the study will have to be withdrawn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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bone turnover markers

Secondary Outcome Measures

Name	Time	Method
<br> 1. Insulin resistance<br> 2. Blood pressure<br> 3. Lipid profile<br> 4. Endothelial function<br> 5. Changes in endometrial thickness<br>