Contact information
Type
Scientific
Primary contact
Prof Marika Mikelsaar
ORCID ID
Contact details
Tartu Ulikool
Ravila 19
Tartu
50411
Estonia
+372 (0)7 374 179
marika.mikelsaar@ut.ee
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
178/T-13
Study information
Scientific title
Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers: a randomised double-blind cross-over trial
Acronym
YOG
Study hypothesis
The consumption of probiotic Lactobacillus plantarum containing yoghurt impacts positively on intestinal microflora, blood pressure and immunological parameters of healthy volunteers.
Ethics approval
Ethics Review Committee on Human Research of the University of Tartu, approved on 19/01/2009 (ref: 178/T-13)
Study design
Randomised double-blind cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Lactobacillus plantarum
Primary outcome measures
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 trial start date
09/03/2009
Overall trial end date
20/05/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
09/03/2009
Recruitment end date
20/05/2009
Locations
Countries of recruitment
Estonia
Trial participating centre
Tartu Ulikool
Tartu
50411
Estonia
Sponsor information
Organisation
Bio-Competence Centre of Healthy Dairy Products Ltd. (Estonia)
Sponsor details
Kreutzwaldi str. 1
Tartu
51014
Estonia
+372 731 3403
ene.tammsaar@emu.ee
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
EU Structural Funds (Estonia) - http://www.struktuurifondid.ee/
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Enterprise Estonia (Estonia) - http://www.eas.ee
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary