Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Khayder Sharafetdinov
ORCID ID
Contact details
2/14 Ustinsky Proezd
Moscow
109240
Russian Federation
+8 (499) 794 3516
sharafandr@mail.ru
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
53k on November 1, 2010
Study information
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
Acronym
Study hypothesis
Probiotic cheese comprising L. plantarum TENSIA under the hypocaloric diet improves the host metabolic markers.
Ethics approval
Institute of Nutrition Ethics Review Committe, Russian Academy of Medical Sciences, 17 November 2010, ref: 77
Study design
Randomized blinded controlled parallel-designed two-armed intervention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
1. Significant decrease of blood pressure
2. Significant decrease of body mass index (BMI)
Secondary outcome measures
Colonization of GI tract with L. plantarum Tensia
Overall trial start date
01/11/2010
Overall trial end date
31/03/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/11/2010
Recruitment end date
31/03/2011
Locations
Countries of recruitment
Russian Federation
Trial participating centre
2/14 Ustinsky Proezd
Moscow
109240
Russian Federation
Sponsor information
Organisation
E-Piim (Estonia)
Sponsor details
c/o Mr Jaanus Murakas
Pikk 16
Järva-Jaani
73301
Estonia
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
E-Piim (Estonia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22642170
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24120179
Publication citations
-
Protocol
Sharafetdinov KhKh, Plotnikova OA, Alekseeva RI, Sentsova TB, Kaganov BS, [Influence of a low-calorie diet with inclusion of probiotic product containing bacterias Lactobacillus plantarum Tensia DSM 21380 on clinical and metabolic characteristics in patients with obesity and arterial hypertension]., Vopr Pitan, 2012, 81, 1, 80-85.
-
Results
Sharafedtinov KK, Plotnikova OA, Alexeeva RI, Sentsova TB, Songisepp E, Stsepetova J, Smidt I, Mikelsaar M, Hypocaloric diet supplemented with probiotic cheese improves body mass index and blood pressure indices of obese hypertensive patients--a randomized double-blind placebo-controlled pilot study., Nutr J, 2013, 12, 138, doi: 10.1186/1475-2891-12-138.