Effect of different doses of L. planatrum TENSIA containing probiotic cheese on clinical parameters of volunteers

ISRCTN	ISRCTN42449576
DOI	https://doi.org/10.1186/ISRCTN42449576
Protocol serial number	190T-10 from 22.02.2010
Sponsor	Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia)
Funder	Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia)

Submission date: 10/03/2010
Registration date: 18/03/2010
Last edited: 18/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika Mikelsaar
Scientific

Ravila str 19
Tartu
50411
Estonia

Email	marika.mikelsaar@ut.ee

Study information

Primary study design	Interventional
Study design	Open interventional dose safety study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of different doses of L. planatrum TENSIA containing probiotic cheese on blood indices and intestinal microflora of healthy adult volunteers: An open label, interventional study
Study acronym	TE 5
Study objectives	1. The consumption of a probiotic Lactobacillus plantarum strain containing cheese in daily (high) dose of 100g (probiotic dose being 10^11 CFU) 1.1. is safe: no negative gastrointestinal effect, no elevated total cholesterol and no negative shifts in cholesterol fractions 1.2. affects positively the functions of the cardio-vascular system of human body. 2. The consumption of a probiotic Lactobacillus plantarum strain containing cheese in daily (low) dose of 100g (probiotic dose being 10^5 Colony Forming Units [CFU]) has positive impact on blood indices of healthy volunteers.
Ethics approval(s)	The Ethics Review Committee on Human Research of the University of Tartu approved on the 22nd of February 2010 (ref: 190T-10)
Health condition(s) or problem(s) studied	blood indices and intestinal microflora
Intervention	Probiotic cheese consumption Group I of volunteers 100 g probiotic cheese once a day for 3 weeks in a daily dose of probitoic being 10^5 CFU Group II of volunteers 100 g probiotic cheese once a day for 3 weeks in a daily dose of probitoic being 10^11 CFU Blood, urine and faecal samples are collected at the recruitment, and after 3 weeks of probiotic treatment Samples of fasting blood, fecal and urine samples will be collected at recruitment and at the end of the trial after administration of the L. plantarum TENSIA comprising cheese.
Intervention type	Other
Primary outcome measure(s)	1. The health indices of study participants are assessed at the recruitment and after 3 weeks of probiotic treatment. 1.1. Height 1.2. Weight 1.3. Body mass index (BMI) 1.4. Blood pressure 2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), is filled once a week during the trial 3. Haematological indices will be determined at the recruitment and after 3 weeks of probiotic treatment. by standard laboratory methods using certified assays in the local clinical laboratory (United Laboratories of Tartu University Clinics, Estonia). 3.1. Haemoglobin 3.2. White blood cell count 3.3. Red blood cells count 3.4. Platelet count 4. Routine biochemical indices will be determined at the recruitment and after 3 weeks of probiotic treatment 4.1. Albumin 4.2. Ferritine 4.3. Plasma glucose 4.4. High-sensitive CRP (hs-CRP) 4.5. Total cholesterol 4.6. LDL-cholesterol (LDL) 4.7. HDL-cholesterol (HDL) 4.8. Triglycerides 4.9. Serum creatinine 4.10. Alanine transaminase (ALAT) 4.11. Aspartate transaminase (ASAT) 4.12. Immunoglobulin IgE levels 5. Safety of high doses of TENSIA
Key secondary outcome measure(s)	Positive impact on human health
Completion date	14/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Wish to participate in the study 2. Aged 18 years and over, both sexes 3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy) 4. Signed informed consent
Key exclusion criteria	1. History of any gastrointestinal disease 2. Use of any antimicrobial drug within last month 3. Use of any regular concomitant medication, including medical preparations 4. Food allergy 5 Pregnancy or breastfeeding
Date of first enrolment	10/05/2010
Date of final enrolment	14/06/2010

Locations

Countries of recruitment

Estonia

Study participating centre

Ravila str 19

Tartu
50411
Estonia

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes