|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers |
| ISRCTN | ISRCTN79645828 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers |
| Scientific title | Effect of probiotic yoghurt comprising L. plantarum strains TENSIA or INDUCIA on blood indices and intestinal microflora of healthy volunteers: A randomised controlled crossover trial |
| Acronym | JOG 2 |
| Serial number at source | 190T-11 |
| Study hypothesis | The consumption of yoghurt containing probiotic L. plantarum strains has positive impact on intestinal microbiota and 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-11) |
| Study design | Randomised double blind dietary crossover intervention 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 | 29/03/2010 |
| Anticipated end date | 24/05/2010 |
| 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 | 120 volunteers recruited from GP clinics (60 per intervention group, subdivided to 30 test subjects & 30 controls) |
| Interventions | The consumption once a day 150g of probiotic yoghurt vs regular yoghurt for 3 weeks. Probiotic yoghurt containing either Lactobacillus plantarum strain TENSIA or INDUCIA (10^9 colony forming units [CFU]/g) After two-week washout period, volunteers are crossed over to another three weeks of probiotic yoghurt or control yoghurt administration. |
| Primary outcome measure(s) |
1. The health indices of study participants (body mass index, blood pressure) are assessed at the recruitment and after 3 weeks of probiotic treatment.
2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial Fasting blood, faecal samples and morning urine will be taken at the recruitment, after 3 weeks of probiotic treatment, after washout and after placebo treatment. 3. Haematological indices will be measured 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 cell count 3.4. Platelet count 3.5. Plasma glucose 3.6. Albumin 3.7. Total cholesterol (TC) 3.8. Low-density lipoprotein cholesterol (LDL) 3.9. High-density lipoprotein cholesterol (HDL) 3.10. Triglyceride 3.11. High-sensitive C-reactive protein (hs-CRP) 3.12. Interleukin 6 (IL-6) 4. Increased counts of total faecal lactobacilli, measured by Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) |
| Secondary outcome measure(s) |
Immunological parameters from blood will be measured by routine biochemical analyses in local clinical lab and also by Evidence investigator
1. Significantly increased circulation of polyamines in host, measured by urine gas chromotography 2. Immune stimulation (both cellular and humoral immunity) |
| 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 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|