Contact information
Type
Scientific
Primary contact
Prof Marika MIkelsaar
ORCID ID
Contact details
Ravila 19
Tartu
50411
Estonia
marika.mikelsaar@ut.ee
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
200-T4 from 17/01/2010
Study information
Scientific title
Effect of probiotic yoghurt comprising L. plantarum strain TENSIA on blood indices and intestinal microflora of healthy volunteers: A randomised controlled crossover trial
Acronym
JOG3
Study hypothesis
The consumption of yoghurt containing probiotic L. plantarum strain TENSIA has positive impact on blood indices of healthy volunteers.
Ethics approval
Ethics Review Committee on Human Research of the University of Tartu approved on the 17th January 2010 (ref: 200-T4)
Study design
Randomised double-blind cross-over intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Blood indices, intestinal microflora
Intervention
The consumption once a day 150 g of probiotic yoghurt versus regular yoghurt for 3 weeks. Probiotic yoghurt containing either Lactobacillus plantarum strain TENSIA (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. Fasting blood samples are collected.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The health indices of study participants (height, weight, body mass index, blood pressure) assessed at the recruitment, after 3 weeks of probiotic treatment, after washout and after 3-week placebo treatment
2. The self-reported questionnaire containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial
3. Haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol, low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, high sensitivity C reactive protein (hs-CRP) and interlukin (IL)-6 measured at the recruitment, after 3 weeks of probiotic treatment, after washout and after 3-week placebo treatment
Secondary outcome measures
Circulation of polyamines in host, oxidised low density lipoprotein (oxLDL), 8-isoprostanes, adiponectine, leptin, cytokines and growth factors (IL1 alfa, IL1beta, IL2, IL4, IL6, IL8, IL10, VEGF, EDG, ITFgamma, TNFalfa, MCP-1), osteoprotegerin
Overall trial start date
07/02/2011
Overall trial end date
04/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Wish to participate in the study
2. Aged 18 years and over, either sex
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
100 persons of both sexes, divided into in two groups
Participant 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
Recruitment start date
07/02/2011
Recruitment end date
04/04/2011
Locations
Countries of recruitment
Estonia
Trial participating centre
Ravila 19
Tartu
50411
Estonia
Sponsor information
Organisation
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)
Sponsor details
Kreutzwaldi 1
Tartu
51014
Estonia
+372 (0)731 3411
ene.tammsaar@tptak.ee
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)
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