Investigation of whey-based dairy products
| ISRCTN | ISRCTN51441547 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51441547 |
| Secondary identifying numbers | 215/T-3 |
- Submission date
- 05/11/2012
- Registration date
- 16/11/2012
- Last edited
- 07/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Prostate complaints, especially those associated with urination, are very common and reduce the quality of life of many men. Every non-pharmaceutical possibility (without the use of medication) to relieve urinary difficulties of men would be valued and it would be the best if a novel food product would have such effect. Thus there is a need for production and use of reliable, test-proven food products and dietary supplements with healthy properties. The use of lactic acid bacteria has been described beneficial for the treatment of urogenital infections, including prostate infection.
The initial studies showed that whey-based lactobacilli-treated special dairy products may have beneficial effect on men with moderate urination problems
Who can participate?
Men aged 45-75 yrs with moderate urination problems
What does the study involve?
Participants are randomly allocated to active or control group
Active group receives fermented whey-based drink (200g per day) for 4 weeks
Control group receives whey-based drink (200g per day) for 4 weeks
What are the possible benefits and risks of participating?
Study participants get assessment of their health status and if necessary, free consultation of a nutritionist and/or a specialist. This health assessment will provide more precise overall health status of participant.
The study causes minimal inconveniences to participants. As blood samples are taken by experienced nurse, the procedure is safe. However, there may be bruising and discomfort at the site of the blood test as with any blood test. The amounts of blood we are taking are small enough that they should not make you feel fatigue or cause anemia.
Where is the study run from?
In andrology clinic in Tartu, Estonia
When is the study starting and how long is it expected to run for?
This study is starting in October 2012, it is expected to complete in January 2014.
Who is funding the study?
The study is funded by the grant from European Union (EU) Structural Funds
Who is the main contact?
Tiiu Kullisaar, PhD
tiiu.kullisaar@ut.ee
Contact information
Scientific
Ravila str 19
Tartu
50411
Estonia
| Phone | +37 27 37 4314 |
|---|---|
| Tiiu.Kullisaar@ut.ee |
Study information
| Study design | Randomized double-blind placebo controlled two armed study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of Whey-Based Dairy Products in the case of the Men With moderate Urination Problems (IPSS score < 19) |
| Study acronym | WBDPMWUP |
| Study objectives | Whey-based lactobacilli-treated special whey products may have effect on men with moderate urination problems. |
| Ethics approval(s) | Research Ethics Committee of the University of Tartu (UT REC), June, 14, 2012, ref:215/T-3 |
| Health condition(s) or problem(s) studied | Moderate urination problems |
| Intervention | Participants randomised to active or control group 1. Active intervention: fermented whey-based drink (200g per day) 2. Control: whey-based drink (200g per day) |
| Intervention type | Other |
| Primary outcome measure | Significant improvement of urinary problems of men with moderate urination problems (IPSS score 8-19) |
| Secondary outcome measures | Improvement / maintenance of clinical, biochemical, immunological and metabolic profile of men with moderate urination problems (IPSS score 8-19) |
| Overall study start date | 31/10/2012 |
| Completion date | 26/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 72 |
| Key inclusion criteria | 1. A written informed consent# 2. Men (45-75 yrs of age) with moderate urination problems (IPSS score 8-19; International Prostate Symptome Score) having next indices: 2.1. Prostate-specific antigen (PSA) <10 ng/mL 2.2. Urinary flow rate 5-15 mL/s 2.3. Prostate volume <80 mL 2.4. Residue urine (measured abdominally) <300 mL |
| Key exclusion criteria | 1. Tumors of urinary tract, prostata, genital tract 2. Suffer from acute strong cholics of the urinary(genital) tract 3. Radio- or chemotherapy of pelvis 4. Prostate operation 5. Using α1- adrenoblocators within last two weeks 6. Using 5 α-reductase inhibitors within last 3 months 7. History of alcohol of drug abuse |
| Date of first enrolment | 31/10/2012 |
| Date of final enrolment | 26/01/2014 |
Locations
Countries of recruitment
- Estonia
Study participating centre
50411
Estonia
Sponsor information
Industry
Kreutzwaldi str 1
Tartu
51014
Estonia
| Phone | +37 27 516 4210 |
|---|---|
| ene.tammsaar@tptak.ee |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/02/2018 | 21/01/2019 | Yes | No |
Editorial Notes
07/02/2022: The sponsor organisation has been changed from "Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)" to "BioCC OÜ".
21/01/2019: Publication reference added
