Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/03/2010
Date assigned
18/03/2010
Last edited
18/03/2010
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

Prof Marika Mikelsaar

ORCID ID

Contact details

Ravila str 19
Tartu
50411
Estonia
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

190T-10 from 22.02.2010

Study information

Scientific title

Effect of different doses of L. planatrum TENSIA containing probiotic cheese on blood indices and intestinal microflora of healthy adult volunteers: An open label, interventional study

Acronym

TE 5

Study hypothesis

1. The consumption of a probiotic Lactobacillus plantarum strain containing cheese in daily (high) dose of 100g (probiotic dose being 10^11 CFU)
1.1. is safe: no negative gastrointestinal effect, no elevated total cholesterol and no negative shifts in cholesterol fractions
1.2. affects positively the functions of the cardio-vascular system of human body.

2. The consumption of a probiotic Lactobacillus plantarum strain containing cheese in daily (low) dose of 100g (probiotic dose being 10^5 Colony Forming Units [CFU]) has positive impact on blood indices of healthy volunteers.

Ethics approval

The Ethics Review Committee on Human Research of the University of Tartu approved on the 22nd of February 2010 (ref: 190T-10)

Study design

Open interventional dose safety study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please contact Dr Pirje Hütt [pirje.hutt@ut.ee] to request a patient information sheet (in Estonian)

Condition

blood indices and intestinal microflora

Intervention

Probiotic cheese consumption
Group I of volunteers 100 g probiotic cheese once a day for 3 weeks in a daily dose of probitoic being 10^5 CFU
Group II of volunteers 100 g probiotic cheese once a day for 3 weeks in a daily dose of probitoic being 10^11 CFU
Blood, urine and faecal samples are collected at the recruitment, and after 3 weeks of probiotic treatment

Samples of fasting blood, fecal and urine samples will be collected at recruitment and at the end of the trial after administration of the L. plantarum TENSIA comprising cheese.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The health indices of study participants are assessed at the recruitment and after 3 weeks of probiotic treatment.
1.1. Height
1.2. Weight
1.3. Body mass index (BMI)
1.4. Blood pressure
2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), is filled once a week during the trial
3. Haematological indices will be determined at the recruitment and after 3 weeks of probiotic treatment. by standard laboratory methods using certified assays in the local clinical laboratory (United Laboratories of Tartu University Clinics, Estonia).
3.1. Haemoglobin
3.2. White blood cell count
3.3. Red blood cells count
3.4. Platelet count
4. Routine biochemical indices will be determined at the recruitment and after 3 weeks of probiotic treatment
4.1. Albumin
4.2. Ferritine
4.3. Plasma glucose
4.4. High-sensitive CRP (hs-CRP)
4.5. Total cholesterol
4.6. LDL-cholesterol (LDL)
4.7. HDL-cholesterol (HDL)
4.8. Triglycerides
4.9. Serum creatinine
4.10. Alanine transaminase (ALAT)
4.11. Aspartate transaminase (ASAT)
4.12. Immunoglobulin IgE levels
5. Safety of high doses of TENSIA

Secondary outcome measures

Positive impact on human health

Overall trial start date

10/05/2010

Overall trial end date

14/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Wish to participate in the study
2. Aged 18 years and over, both sexes
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

Adult

Gender

Both

Target number of participants

40 recruited from GP clinics, divided into in two groups

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

Recruitment start date

10/05/2010

Recruitment end date

14/06/2010

Locations

Countries of recruitment

Estonia

Trial participating centre

Ravila str 19
Tartu
50411
Estonia

Sponsor information

Organisation

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

Sponsor details

Kreutzwaldi str 1
Tartu
51014
Estonia
+372 (0)731 3411
ene.tammsaar@tptak.ee

Sponsor type

Industry

Website

http://www.tptak.ee

Funders

Funder type

Industry

Funder name

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

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

Publication citations

Additional files

Editorial Notes