Effect of probiotic cheese on blood indices and intestinal microflora of healthy volunteers and elderly individuals

ISRCTN	ISRCTN15061552
DOI	https://doi.org/10.1186/ISRCTN15061552
Protocol serial number	184/T-10
Sponsor	Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Funders	Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre, University of Tartu (Estonia) - Department of Microbiology, Faculty of Medicine

Submission date: 18/09/2009
Registration date: 02/10/2009
Last edited: 08/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Epp Songisepp
Scientific

Ravila 19
Tartu
50411
Estonia

Phone	+372 (0)5 027 239
Email	esongisepp@gmail.com

Study information

Primary study design	Interventional
Study design	Randomised double-blind dietary cross-over intervention study
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
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
Study acronym	TE4
Study objectives	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(s)	Ethics Review Committee on Human Research of the University of Tartu, 26/08/2009, ref: 184/T-10
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	28/11/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Lower age limit	18 Years
Sex	All
Target sample size at registration	210
Key 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
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 (Group I)
Date of first enrolment	05/10/2009
Date of final enrolment	28/11/2009

Locations

Countries of recruitment

Estonia

Study participating centre

Ravila 19

Tartu
50411
Estonia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/03/2016: Publication reference added.