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Probiotic cheese in hypocaloric diet
ISRCTN ISRCTN76271778
DOI 10.1186/ISRCTN76271778
ClinicalTrials.gov identifier
EudraCT number
Public title Probiotic cheese in hypocaloric diet
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 N/A
Serial number at source 53k on November 1, 2010
Study hypothesis Probiotic cheese comprising L. plantarum TENSIA under the hypocaloric diet improves the host metabolic markers.
Lay summary Lay summary under review 3
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
Countries of recruitment Russian Federation
Disease/condition/study domain Metabolic syndrome with hypertension
Participants - 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
Participants - 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
Anticipated start date 01/11/2010
Anticipated end date 31/03/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 40
Interventions 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.
Primary outcome measure(s) 1. Significant decrease of blood pressure
2. Significant decrease of body mass index (BMI)
Secondary outcome measure(s) Colonization of GI tract with L. plantarum Tensia
Sources of funding E-Piim (Estonia)
Trial website
Publications 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22642170
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24120179
Contact name Prof  Khayder  Sharafetdinov
  Address 2/14 Ustinsky Proezd
  City/town Moscow
  Zip/Postcode 109240
  Country Russian Federation
  Tel +8 (499) 794 3516
  Fax +8 (499) 794 3516
  Email sharafandr@mail.ru
Sponsor E-Piim (Estonia)
  Address c/o Mr Jaanus Murakas
Pikk 16
  City/town Järva-Jaani
  Zip/Postcode 73301
  Country Estonia
  Sponsor website: http://www.epiim.ee/en
Date applied 29/10/2012
Last edited 23/07/2014
Date ISRCTN assigned 15/11/2012
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