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

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-11

Study information

Scientific title

Effect of probiotic yoghurt comprising L. plantarum strains TENSIA or INDUCIA on blood indices and intestinal microflora of healthy volunteers: A randomised controlled crossover trial

Acronym

JOG 2

Study hypothesis

The consumption of yoghurt containing probiotic L. plantarum strains has positive impact on intestinal microbiota and blood indices of healthy volunteers.

Ethics approval

The Ethics Review Committee on Human Research of the University of Tartu, 22/02/2010, ref: 190T-11

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 contact Dr Pirje Hütt [pirje.hutt@ut.ee] to request a patient information sheet (in Estonian)

Condition

Blood indices and intestinal microflora

Intervention

The consumption once a day 150g of probiotic yoghurt vs regular yoghurt for 3 weeks. Probiotic yoghurt containing either Lactobacillus plantarum strain TENSIA or INDUCIA (10^9 colony forming units [CFU]/g) After two-week washout period, volunteers are crossed over to another three weeks of probiotic yoghurt or control yoghurt administration.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

1. The health indices of study participants (body mass index, blood pressure) are assessed at the recruitment and after 3 weeks of probiotic treatment.
2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial

Fasting blood, faecal samples and morning urine will be taken at the recruitment, after 3 weeks of probiotic treatment, after washout and after placebo treatment.
3. Haematological indices will be measured 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 cell count
3.4. Platelet count
3.5. Plasma glucose
3.6. Albumin
3.7. Total cholesterol (TC)
3.8. Low-density lipoprotein cholesterol (LDL)
3.9. High-density lipoprotein cholesterol (HDL)
3.10. Triglyceride
3.11. High-sensitive C-reactive protein (hs-CRP)
3.12. Interleukin 6 (IL-6)
4. Increased counts of total faecal lactobacilli, measured by Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR)

Secondary outcome measures

Immunological parameters from blood will be measured by routine biochemical analyses in local clinical lab and also by Evidence investigator
1. Significantly increased circulation of polyamines in host, measured by urine gas chromotography
2. Immune stimulation (both cellular and humoral immunity)

Overall trial start date

29/03/2010

Overall trial end date

24/05/2010

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

120 volunteers recruited from GP clinics (60 per intervention group, subdivided to 30 test subjects & 30 controls)

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

29/03/2010

Recruitment end date

24/05/2010

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25524863

Publication citations

Additional files

Editorial Notes

08/03/2016: Publication reference added.