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 |
| Protocol serial number | 7962 |
| Sponsor | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Funder | Food Standards Agency (FSA) (UK) |
- 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
Scientific
Brocklehurst Building
Miranda House
216-258 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A double-blind placebo-controlled parallel trial of soy phytoestrogens in patients with type 2 diabetes and borderline low testosterone levels |
| Study acronym | DRN 431 (Soy and testosterone in men with diabetes) |
| Study objectives | 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(s) | MREC approved, ref: 09/H1304/45 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Soy protein, phytoestrogen |
| Primary outcome measure(s) |
Quantify the magnitude |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 12/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 250 |
| Total final enrolment | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/06/2010 |
| Date of final enrolment | 12/12/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Brocklehurst Building
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
