Condition category
Not Applicable
Date applied
25/02/2009
Date assigned
06/03/2009
Last edited
06/03/2009
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

Tartu Ulikool
Ravila 19
Tartu
50411
Estonia
+372 (0)7 374 179
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

178/T-13

Study information

Scientific title

Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers: a randomised double-blind cross-over trial

Acronym

YOG

Study hypothesis

The consumption of probiotic Lactobacillus plantarum containing yoghurt impacts positively on intestinal microflora, blood pressure and immunological parameters of healthy volunteers.

Ethics approval

Ethics Review Committee on Human Research of the University of Tartu, approved on 19/01/2009 (ref: 178/T-13)

Study design

Randomised double-blind cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intestinal microflora, blood pressure and immunological parameters of healthy adults

Intervention

Probiotic yoghurt consumption versus regular yoghurt consumption. Volunteers are randomly allocated to receive either:
1. 150 g probiotic yoghurt (group 1) or control yoghurt (group 2) once a day for 3 weeks. Probiotic yoghurt containing Lactobacillus plantarum strain 3 x 10^9 colony forming units [CFU] per g of yoghurt.
2. After a two-week washout period, volunteers will be crossed over to another three weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lactobacillus plantarum

Primary outcome measures

The following will be measured at recruitment, after 3-week intervention, after 2-week washout and at the end of another 3-week intervention:
1. Clinical blood indices
2. Intestinal microflora

Secondary outcome measures

The following will be measured at recruitment, after 3-week intervention, after 2-week washout and at the end of the trial i.e. at the end of another 3-week intervention:
1. The self-reported questionnaire containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency)
2. Haematological indices, plasma glucose, total cholesterol (TC), high density lipoprotein (HDL) and low density lipoprotein (LDL) cholesterol, triglyceride and high sensitivity C-reactive protein (hsCRP), Interleukin-6 (IL-6), immunoglobulin levels
3. The content of biogenic amines and polyamines in urine
4. Reverse transcription polymerase chain reaction (RT-PCR) from fecal samples for monitoring the changes in the counts of lactoflora, L. planatrum and survival of the administered strains
5. Denaturing gradient gel electrophoresis (DGGE) used to monitor changes in total fecal microflora after yoghurt consumption

Overall trial start date

09/03/2009

Overall trial end date

20/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Wish to participate in the study
2. Both males and females, aged 18-65 years
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

60

Participant exclusion criteria

1. History of any gastrointestinal disease
2. Use of any antimicrobial agent within the preceding month
3. Use of any regular concomitant medication including non-steroidal anti-inflammatory drugs and antioxidant vitamins
4. Pregnancy or breastfeeding
5. Food allergy
6. Diabetes and acute infections

Recruitment start date

09/03/2009

Recruitment end date

20/05/2009

Locations

Countries of recruitment

Estonia

Trial participating centre

Tartu Ulikool
Tartu
50411
Estonia

Sponsor information

Organisation

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

Sponsor details

Kreutzwaldi str. 1
Tartu
51014
Estonia
+372 731 3403
ene.tammsaar@emu.ee

Sponsor type

Industry

Website

http://www.tptak.ee

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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