Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7962
Study information
Scientific title
A double-blind placebo-controlled parallel trial of soy phytoestrogens in patients with type 2 diabetes and borderline low testosterone levels
Acronym
DRN 431 (Soy and testosterone in men with diabetes)
Study hypothesis
The aim of this study is to determine if 15 g of soy protein (isoflavone free) alone versus 15 g soy protein with 66 mg of isoflavones given in two daily divided doses, has an effect on testosterone levels in men who have borderline or subclinical (without symptoms) hypogonadism.
Ethics approval
MREC approved, ref: 09/H1304/45
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Metabolic
Intervention
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 (Solcon F) with 33 mg of isoflavones (given twice daily) or 7.5 g of the isolated soy (extracted isoflavone free) protein alone (given twice daily) as control will be administered.
Follow-up length: 3 months
Intervention type
Drug
Phase
Not Applicable
Drug names
Soy protein, phytoestrogen
Primary outcome measure
Quantify the magnitude
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/06/2010
Overall trial end date
12/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned sample size: 250; UK sample size: 250
Total final enrolment
200
Participant 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
Recruitment start date
10/06/2010
Recruitment end date
12/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brocklehurst Building
Hull
HU3 2RW
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
Medical Research
Teaching and Day Surgery Building
Daisy Building
Castle Hill Hospital
Castle Road
Hull
HU16 5JQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Food Standards Agency (FSA) (UK)
Alternative name(s)
FSA
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5684229/
2. 2018 results relating to effect on thyroid hormone levels in https://www.ncbi.nlm.nih.gov/pubmed/30524380
3. 2019 follow-up analysis in: https://www.ncbi.nlm.nih.gov/pubmed/31031706