Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers
| ISRCTN | ISRCTN79645828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79645828 |
| Secondary identifying numbers | 190T-11 |
- Submission date
- 10/03/2010
- Registration date
- 18/03/2010
- Last edited
- 16/12/2022
- 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
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 | Randomised double-blind dietary cross-over intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 probiotic yoghurt comprising L. plantarum strains TENSIA or INDUCIA on blood indices and intestinal microflora of healthy volunteers: A randomised controlled crossover trial |
| Study acronym | JOG 2 |
| Study objectives | The consumption of yoghurt containing probiotic L. plantarum strains has positive impact on intestinal microbiota and blood indices of healthy volunteers. |
| Ethics approval(s) | The Ethics Review Committee on Human Research of the University of Tartu, 22/02/2010, ref: 190T-11 |
| Health condition(s) or problem(s) studied | Blood indices and intestinal microflora |
| Intervention | 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. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 29/03/2010 |
| Completion date | 24/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 volunteers recruited from GP clinics (60 per intervention group, subdivided to 30 test subjects & 30 controls) |
| 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 | 29/03/2010 |
| Date of final enrolment | 24/05/2010 |
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | Yes | No | |
| Results article | 01/05/2022 | 16/12/2022 | Yes | No |
Editorial Notes
16/12/2022: Publication reference added.
08/03/2016: Publication reference added.
