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

ISRCTN ISRCTN45791894
DOI https://doi.org/10.1186/ISRCTN45791894
Secondary identifying numbers 177 /T-13
Submission date
18/03/2009
Registration date
30/04/2009
Last edited
02/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika Mikelsaar
Scientific

Ravila str 19
Tartu
50411
Estonia

Phone +372 (0)7 374 179
Email marika.mikelsaar@ut.ee

Study information

Study designRandomised double-blind dietary cross-over intervention study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of probiotic cheese on blood indices and intestinal microflora of healthy elderly volunteers: a randomised, double-blind, dietary cross-over intervention study
Study objectivesThe consumption of probiotic Lactobacillus plantarum-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 approved on the 12th December 2008 (ref: 177/T-13)
Health condition(s) or problem(s) studiedIntestinal microflora
InterventionProbiotic cheese consumption versus control cheese consumption. Volunteers were randomly allocated to receive either:
1. 50 g probiotic cheese (containing Lactobacillus plantarum strain 3 x 10^9 Colony Forming Units [CFU] per gram of cheese) (group 1, n = 12) once a day for three weeks
2. 50 g control cheese (group 2, n = 12) once a day for three weeks

After a two-week wash-out period, volunteers were crossed over to another three weeks of probiotic cheese or control cheese administration.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)Lactobacillus plantarum
Primary outcome measureTo assess the safety of cheese comprising the probiotic Lactobacillus plantarum strain in healthy elderly subjects. The survival of the probiotic strain in gastrointestinal tract (GIT) and its effect on intestinal microflora and clinical blood indices of healthy volunteers will be measured at the recruitment, after a 3-week of probiotic treatment, after a 2-week wash-out and after a 3-week placebo treatment.
Secondary outcome measures1. 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
2. The assessment of the health indices of healthy elderly (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
3. 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
4. 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), immunoglobulins (IgA, IgM, IgG) levels 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 urines 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 clostridia (including C. difficile), total anaerobes, enterococci, E. coli and lactic acid bacteria
Overall study start date03/01/2009
Completion date30/04/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants24 elderly volunteers (both sexes)
Key inclusion criteria1. Wish to participate in the study
2. Aged over 65 years, either sex
3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy)
4. Signed informed consent
Key exclusion criteria1. 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
Date of first enrolment03/01/2009
Date of final enrolment30/04/2009

Locations

Countries of recruitment

  • Estonia

Study participating centre

Ravila str 19
Tartu
50411
Estonia

Sponsor information

Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Industry

Kreutzwaldi str. 1
Tartu
51014
Estonia

Phone +372 (0)731 3403
Email Ene.Tammsaar@emu.ee
Website http://www.tptak.ee
ROR logo "ROR" https://ror.org/02e801388

Funders

Funder type

Government

Estonian Science Foundation (Estonia) - http://www.etf.ee/

No information available

EU Structural Funds (Estonia) - http://www.struktuurifondid.ee/

No information available

Enterprise Estonia (Estonia) - http://www.eas.ee

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2012 Yes No