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A double-blind placebo-controlled parallel trial of soy phytoestrogens in patients with type 2 diabetes and borderline low testosterone levels

A double-blind placebo-controlled parallel trial of soy phytoestrogens in patients with type 2 diabetes and borderline low testosterone levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN90604927
Enrollment
250
Registered
2010-05-19
Start date
2010-06-10
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

Topic: Diabetes Research Network

Interventions

There will be a three month phase of treatment with either active (15 g soy protein with 66 mg phytoestrogen) or control (15 g soy protein alone). A bar containing 7.5 g isolated soy protein powder (S

Sponsors

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

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Diagnosis of type 2 diabetes 2. Patients will be on stable medication for their diabetes, hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study 3. Age between 45 - 75 years at the start of the study, male only 4. Serum testosterone value of 12 nmol/L or less (normal range 1236 nmol/L) and who are symptom free will be eligible to participate

Exclusion criteria

Exclusion criteria: 1. Patients with concurrent illness or any medication in the last 3 months 2. Patients not wishing to allow disclosure to their GPs 3. Patients who are taking hormone replacement therapy 4. Patients who are currently or have taken antibiotics in the last 3 months 5. Hba1c at recruiting stage of greater than 9% 6. Vegetarians 7. Smokers 8. Patients with known food allergies

Design outcomes

Primary

MeasureTime frame
Quantify the magnitude

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026