Contact information
Type
Scientific
Primary contact
Dr Epp Songisepp
ORCID ID
Contact details
Ravila 19
Tartu
50411
Estonia
+372 (0)5 027 239
esongisepp@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
184/T-10
Study information
Scientific title
Effect of probiotic cheese on blood indices and intestinal microflora of healthy adult and healthy elderly volunteers: a randomised, double-blind, dietary cross-over intervention study
Acronym
TE4
Study hypothesis
1. The consumption of a probiotic Lactobacillus plantarum strain containing cheese affects positively the functions of the cardio-vascular system of human body. There is a negative correlation between the counts of fecal lactobacilli counts and blood pressure.
2. The consumption of a probiotic Lactobacillus plantarum strain containing cheese has positive impact on intestinal microbiota and blood indices of healthy volunteers
Ethics approval
Ethics Review Committee on Human Research of the University of Tartu, 26/08/2009, ref: 184/T-10
Study design
Randomised double-blind dietary cross-over intervention study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Blood indices and intestinal microflora
Intervention
Probiotic cheese consumption versus regular cheese consumption.
Group I:
Volunteers are randomly allocated to receive either:
1. 50 g probiotic cheese or control cheese once a day for 3 weeks. Probiotic cheese containing Lactobacillus plantarum strain 10^9 colony forming units [CFU] per g of cheese
2. After two-week washout period, volunteers are crossed over to another three weeks of probiotic cheese or control cheese administration.
Group II:
Volunteers receive once 50 g of cheese containing L. plantarum strain 10^9 CFU/g and 4 days later 50 g of control cheese.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measures
Group I:
Blood, urine and faecal samples are collected at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment. The survival of the probiotic strain in gastrointestinal tract (GIT) and its effect on intestinal microflora and clinical blood indices of healthy volunteers is measured.
Group II:
At the recruitment and 6 hours after cheese consumption the arterial elasticity will be assessed. After 6 hours another blood sample is collected and after 4 days the whole procedure is repeated.
Secondary outcome measures
Group I:
1. The assessment of the health indices of study participants (body mass index, blood pressure), measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment
2. The self-reported questionnaire is applied containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial
3. To determine haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out and after a 3-week placebo treatment
5. Biogenic amines from urine samples will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment
6. Faecal samples will be analysed for the changes in the counts of lactic acid bacteria
Group II:
1. The assessment of the health indices of study participants (body mass index, blood pressure), measured at recruitment
2. Faecal samples are collected at recruitment and will be analysed for the changes in the counts of lactic acid bacteria
3. Haematological indices will be measured at recruitment and 6 hours later (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), IgM, IgA, IgG, oxidative stress markers: oxLDL, several cytockines and growth factors (IL1alfa, IL1beta, IL2, IL4, IL6, IL8, IL10, VEGF, EDG, ITF-gamma, TNFalfa, MCP-1)
4. 8-isoprostanes and creatinine is measured from the urine samples collected at recruitment
Overall trial start date
05/10/2009
Overall trial end date
28/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Wish to participate in the study
2. Aged 18 years and over (group I), aged over 60 (Group II), 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
Other
Gender
Both
Target number of participants
Two groups of volunteers: Group I: 200 persons and Group II: 10 persons
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 (Group I)
Recruitment start date
05/10/2009
Recruitment end date
28/11/2009
Locations
Countries of recruitment
Estonia
Trial participating centre
Ravila 19
Tartu
50411
Estonia
Sponsor information
Organisation
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Sponsor details
Kreutzwaldi 1
Tartu
51014
Estonia
+372 (0)7 313 411
ene.tammsaar@emu.ee
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Tartu (Estonia) - Department of Microbiology, Faculty of Medicine
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25524863