Probiotic cheese in hypocaloric diet

ISRCTN	ISRCTN76271778
DOI	https://doi.org/10.1186/ISRCTN76271778
Secondary identifying numbers	53k on November 1, 2010

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Khayder Sharafetdinov
Scientific

2/14 Ustinsky Proezd
Moscow
109240
Russian Federation

Phone	+8 (499) 794 3516
Email	sharafandr@mail.ru

Study information

Study design	Randomized blinded controlled parallel-designed two-armed intervention trial
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	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	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 study start date	01/11/2010
Completion date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

2/14 Ustinsky Proezd

Moscow
109240
Russian Federation

Sponsor information

E-Piim (Estonia)
Industry

c/o Mr Jaanus Murakas
Pikk 16
Järva-Jaani
73301
Estonia

Website	http://www.epiim.ee/en
"ROR"	https://ror.org/03by5ya49

Funders

Funder type

Industry

E-Piim (Estonia)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/08/2012		Yes	No
Results article	results	12/10/2013		Yes	No