Probiotic cheese in hypocaloric diet
| ISRCTN | ISRCTN76271778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76271778 |
| Protocol serial number | 53k on November 1, 2010 |
| Sponsor | E-Piim (Estonia) |
| Funder | E-Piim (Estonia) |
- Submission date
- 29/10/2012
- Registration date
- 15/11/2012
- Last edited
- 27/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Metabolic syndrome is a combination of diabetes, high blood pressure and obesity, which puts you at greater risk of heart disease, stroke and other conditions affecting the blood vessels. The aim of this study is to assess the effectiveness of a low-calorie diet supplemented with probiotic cheese in adult patients with obesity and high blood pressure.
Who can participate?
Obese people aged 30-69 with high blood pressure.
What does the study involve?
Participants are randomly allocated to one of two groups. One group consumes a low-calorie diet supplemented with 50g per day of probiotic cheese. The other group consumes a low-calorie diet supplemented with 50g per day of regular cheese. The study lasts for 3 weeks, and participants are asked to provide blood, urine and fecal samples to test the effects of the probiotic.
What are the possible benefits and risks of participating?
The study causes minimal inconveniences to participants. As blood samples are taken by an
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?
The Clinic of the Institute of Nutrition, Russian Academy of Medical Sciences.
When is the study starting and how long is it expected to run for?
November 2010 to March 2011.
Who is funding the study?
Clinic of the Institute of Nutrition, Russian Academy of Medical Sciences.
Who is the main contact?
Prof Khayder Sharafetdinov
sharafandr@mail.ru
Contact information
Scientific
2/14 Ustinsky Proezd
Moscow
109240
Russian Federation
| Phone | +8 (499) 794 3516 |
|---|---|
| sharafandr@mail.ru |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized blinded controlled parallel-designed two-armed intervention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Study of the efficiency of dietary inclusion of a probiotic product containing Lactobacillus plantarum Tensia™ DSM 21380 in obese patients with arterial hypertension |
| Study objectives | Probiotic cheese comprising L. plantarum TENSIA under the hypocaloric diet improves the host metabolic markers. |
| Ethics approval(s) | Institute of Nutrition Ethics Review Committe, Russian Academy of Medical Sciences, 17 November 2010, ref: 77 |
| Health condition(s) or problem(s) studied | Metabolic syndrome with hypertension |
| Intervention | Standard treatment with hypocaloric diet with 50g of regular cheese for control group. Standard treatment with hypocaloric diet with 50g/day probiotic cheese for test group. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Significant decrease of blood pressure |
| Key secondary outcome measure(s) |
Colonization of GI tract with L. plantarum Tensia |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Age 30-69 years 2. Diagnosis of metabolic syndrome characterized by obesity accompanied with arterial hypertonia (>130/85 mm Hg) 3. Absence of decompensated chronic diseases needing intensive treatment 4. Informed consent |
| Key exclusion criteria | 1. A history of gastrointestinal disease 2. Food allergy and acute infection 3. Use of any antimicrobial agent within the preceeding month 4. Pregnancy and breastfeeding 5. No wish to participate |
| Date of first enrolment | 01/11/2010 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
109240
Russian Federation
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 | 12/10/2013 | Yes | No | |
| Protocol article | protocol | 01/08/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
