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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34051237
Enrollment
200
Registered
2012-09-05
Start date
2012-09-29
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

A bar containing 7.5g isolated soy protein powder (Solcon F) with 33mg of isoflavones (given twice daily) or 7.5g of the isolated soy (extracted, isoflavone free) protein alone (given twice daily) as

Sponsors

Hull and East Yorkshire Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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 This will also mean that patients who start taking antibiotics during the study will have to be withdrawn 4.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

Design outcomes

Primary

MeasureTime frame
Change in bone turnover markers

Secondary

MeasureTime frame
1. Insulin resistance 2. Blood pressure 3. Lipid profile 4. Endothelial function 5. Changes in endometrial thickness

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026