Condition category
Digestive System
Date applied
18/09/2009
Date assigned
02/10/2009
Last edited
08/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.tptak.ee

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

Publication citations

Additional files

Editorial Notes

08/03/2016: Publication reference added.