Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
19/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Nalumon Parnwell

ORCID ID

Contact details

Brocklehurst Building
Miranda House
216-258 Anlaby Road
Hull
HU3 2RW
United Kingdom

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 measures

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

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

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

http://www.hey.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/10/2016: No publications found in PubMed, verifying study status with principal investigator. 13/12/2013: The anticipated start date was changed from 01/10/2009 to 10/06/2010 and the anticipated end date was changed from 01/01/2010 to 12/12/2013.