Plain English Summary

Lay summary under review 3

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

Screening

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

http://www.epiim.ee/en

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

  1. 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.

  2. 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.

Editorial Notes