Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers
| ISRCTN | ISRCTN68198472 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68198472 |
| Secondary identifying numbers | 178/T-13 |
- Submission date
- 25/02/2009
- Registration date
- 06/03/2009
- Last edited
- 06/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Tartu Ulikool
Ravila 19
Tartu
50411
Estonia
| Phone | +372 (0)7 374 179 |
|---|---|
| marika.mikelsaar@ut.ee |
Study information
| Study design | Randomised double-blind cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers: a randomised double-blind cross-over trial |
| Study acronym | YOG |
| Study objectives | The consumption of probiotic Lactobacillus plantarum containing yoghurt impacts positively on intestinal microflora, blood pressure and immunological parameters of healthy volunteers. |
| Ethics approval(s) | Ethics Review Committee on Human Research of the University of Tartu, approved on 19/01/2009 (ref: 178/T-13) |
| Health condition(s) or problem(s) studied | Intestinal microflora, blood pressure and immunological parameters of healthy adults |
| Intervention | Probiotic yoghurt consumption versus regular yoghurt consumption. Volunteers are randomly allocated to receive either: 1. 150 g probiotic yoghurt (group 1) or control yoghurt (group 2) once a day for 3 weeks. Probiotic yoghurt containing Lactobacillus plantarum strain 3 x 10^9 colony forming units [CFU] per g of yoghurt. 2. After a two-week washout period, volunteers will be crossed over to another three weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lactobacillus plantarum |
| Primary outcome measure | The following will be measured at recruitment, after 3-week intervention, after 2-week washout and at the end of another 3-week intervention: 1. Clinical blood indices 2. Intestinal microflora |
| Secondary outcome measures | The following will be measured at recruitment, after 3-week intervention, after 2-week washout and at the end of the trial i.e. at the end of another 3-week intervention: 1. The self-reported questionnaire containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency) 2. Haematological indices, plasma glucose, total cholesterol (TC), high density lipoprotein (HDL) and low density lipoprotein (LDL) cholesterol, triglyceride and high sensitivity C-reactive protein (hsCRP), Interleukin-6 (IL-6), immunoglobulin levels 3. The content of biogenic amines and polyamines in urine 4. Reverse transcription polymerase chain reaction (RT-PCR) from fecal samples for monitoring the changes in the counts of lactoflora, L. planatrum and survival of the administered strains 5. Denaturing gradient gel electrophoresis (DGGE) used to monitor changes in total fecal microflora after yoghurt consumption |
| Overall study start date | 09/03/2009 |
| Completion date | 20/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Wish to participate in the study 2. Both males and females, aged 18-65 years 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 agent within the preceding month 3. Use of any regular concomitant medication including non-steroidal anti-inflammatory drugs and antioxidant vitamins 4. Pregnancy or breastfeeding 5. Food allergy 6. Diabetes and acute infections |
| Date of first enrolment | 09/03/2009 |
| Date of final enrolment | 20/05/2009 |
Locations
Countries of recruitment
- Estonia
Study participating centre
Tartu Ulikool
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 | +372 731 3403 |
|---|---|
| ene.tammsaar@emu.ee | |
| Website | http://www.tptak.ee |
"ROR" |
https://ror.org/02e801388 |
Funders
Funder type
Government
EU Structural Funds (Estonia) - http://www.struktuurifondid.ee/
No information available
Enterprise Estonia (Estonia) - http://www.eas.ee
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 |
