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11 February 2012
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| [ Print-friendly version ] |
| Effect of different doses of L. planatrum TENSIA containing probiotic cheese on clinical parameters of volunteers |
| ISRCTN | ISRCTN42449576 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of different doses of L. planatrum TENSIA containing probiotic cheese on clinical parameters of volunteers |
| 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 |
| Acronym | TE 5 |
| Serial number at source | 190T-10 from 22.02.2010 |
| Study hypothesis |
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. |
| Lay summary | |
| Ethics approval | The Ethics Review Committee on Human Research of the University of Tartu approved on the 22nd of February 2010 (ref: 190T-10) |
| Study design | Open interventional dose safety study |
| Countries of recruitment | Estonia |
| Disease/condition/study domain | blood indices and intestinal microflora |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 10/05/2010 |
| Anticipated end date | 14/06/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please contact Dr Pirje Hütt [pirje.hutt@ut.ee] to request a patient information sheet (in Estonian) |
| Target number of participants | 40 recruited from GP clinics, divided into in two groups |
| Interventions |
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. |
| 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 |
| Secondary outcome measure(s) | Positive impact on human health |
| Sources of funding | Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia) |
| Trial website | |
| Publications | |
| Contact name | Prof Marika Mikelsaar |
| Address | Ravila str 19 |
| City/town | Tartu |
| Zip/Postcode | 50411 |
| Country | Estonia |
| marika.mikelsaar@ut.ee | |
| Sponsor | Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia) |
| Address | Kreutzwaldi str 1 |
| City/town | Tartu |
| Zip/Postcode | 51014 |
| Country | Estonia |
| Tel | +372 (0)731 3411 |
| ene.tammsaar@tptak.ee | |
| Sponsor website: | http://www.tptak.ee |
| Date applied | 10/03/2010 |
| Last edited | 18/03/2010 |
| Date ISRCTN assigned | 18/03/2010 |
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