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

ISRCTN ISRCTN90604927
DOI https://doi.org/10.1186/ISRCTN90604927
Secondary identifying numbers 7962
Submission date
19/05/2010
Registration date
19/05/2010
Last edited
30/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Nalumon Parnwell
Scientific

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

Study information

Study designMulticentre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific titleA double-blind placebo-controlled parallel trial of soy phytoestrogens in patients with type 2 diabetes and borderline low testosterone levels
Study acronymDRN 431 (Soy and testosterone in men with diabetes)
Study objectivesThe 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(s)MREC approved, ref: 09/H1304/45
Health condition(s) or problem(s) studiedTopic: Diabetes Research Network; Subtopic: Type 2; Disease: Metabolic
InterventionThere 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Soy protein, phytoestrogen
Primary outcome measureQuantify the magnitude
Secondary outcome measuresNot provided at time of registration
Overall study start date10/06/2010
Completion date12/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participantsPlanned sample size: 250; UK sample size: 250
Total final enrolment200
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment10/06/2010
Date of final enrolment12/12/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Brocklehurst Building
Hull
HU3 2RW
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre

Medical Research, Teaching and Day Surgery Building
Daisy Building
Castle Hill Hospital
Castle Road
Hull
HU16 5JQ
England
United Kingdom

Website http://www.hey.nhs.uk
ROR logo "ROR" https://ror.org/01b11x021

Funders

Funder type

Government

Food Standards Agency (FSA) (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
The Food Standards Agency, FSA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2017 Yes No
Results article results relating to effect on thyroid hormone levels 22/11/2018 Yes No
Other publications follow-up analysis 11/04/2019 Yes No

Editorial Notes

30/04/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
17/12/2018: Publication reference added.
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.