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 |
| Secondary identifying numbers | 184/T-10 |
- 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
Scientific
Ravila 19
Tartu
50411
Estonia
| Phone | +372 (0)5 027 239 |
|---|---|
| esongisepp@gmail.com |
Study information
| Study design | Randomised double-blind dietary cross-over intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 05/10/2009 |
| Completion date | 28/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Two groups of volunteers: Group I: 200 persons and Group II: 10 persons |
| 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
50411
Estonia
Sponsor information
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Industry
Industry
Kreutzwaldi 1
Tartu
51014
Estonia
| Phone | +372 (0)7 313 411 |
|---|---|
| ene.tammsaar@emu.ee | |
| Website | http://www.tptak.ee |
"ROR" |
https://ror.org/02e801388 |
Funders
Funder type
Industry
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
No information available
University of Tartu (Estonia) - Department of Microbiology, Faculty of Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2015 | Yes | No |
Editorial Notes
08/03/2016: Publication reference added.
