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 |
| Secondary identifying numbers | 190T-10 from 22.02.2010 |
- 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
Scientific
Ravila str 19
Tartu
50411
Estonia
| marika.mikelsaar@ut.ee |
Study information
| Study design | Open interventional dose safety study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please contact Dr Pirje Hütt [pirje.hutt@ut.ee] to request a patient information sheet (in Estonian) |
| 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 | 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 measures | Positive impact on human health |
| Overall study start date | 10/05/2010 |
| Completion date | 14/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 recruited from GP clinics, divided into in two groups |
| 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
50411
Estonia
Sponsor information
Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia)
Industry
Industry
Kreutzwaldi str 1
Tartu
51014
Estonia
| Phone | +372 (0)731 3411 |
|---|---|
| ene.tammsaar@tptak.ee | |
| Website | http://www.tptak.ee |
"ROR" |
https://ror.org/02e801388 |
Funders
Funder type
Industry
Bio-Competence Centre of Healthy Dairy Products Ltd (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 |
