Effect of probiotic cheese on blood indices and intestinal microflora of healthy elderly volunteers
ISRCTN | ISRCTN45791894 |
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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
Scientific
Ravila str 19
Tartu
50411
Estonia
Phone | +372 (0)7 374 179 |
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marika.mikelsaar@ut.ee |
Study information
Study design | Randomised double-blind dietary cross-over intervention study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Effect of probiotic cheese on blood indices and intestinal microflora of healthy elderly volunteers: a randomised, double-blind, dietary cross-over intervention study |
Study objectives | The 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) studied | Intestinal microflora |
Intervention | Probiotic 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase I |
Drug / device / biological / vaccine name(s) | Lactobacillus plantarum |
Primary outcome measure | To 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 measures | 1. 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 date | 03/01/2009 |
Completion date | 30/04/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 24 elderly volunteers (both sexes) |
Key inclusion criteria | 1. 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 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 |
Date of first enrolment | 03/01/2009 |
Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Estonia
Study participating centre
Ravila str 19
Tartu
50411
Estonia
50411
Estonia
Sponsor information
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Industry
Industry
Kreutzwaldi str. 1
Tartu
51014
Estonia
Phone | +372 (0)731 3403 |
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Ene.Tammsaar@emu.ee | |
Website | http://www.tptak.ee |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/10/2012 | Yes | No |