Condition category
Digestive System
Date applied
24/01/2011
Date assigned
04/03/2011
Last edited
04/03/2011
Prospective/Retrospective
Retrospectively 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 19
Tartu
50411
Estonia
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

199/T6 from 20.12.2010

Study information

Scientific title

Effect of probiotic yoghurt comprising L. plantarum strain INDUCIA on blood indices and intestinal microflora of healthy volunteers: a randomised controlled crossover trial

Acronym

JOG3

Study hypothesis

The consumption of yoghurt containing probiotic L. plantarum strain has positive impact on blood indices of healthy volunteers.

Ethics approval

Ethics Review Committee on Human Research of the University of Tartu approved on the 20th December 2010 (ref: 199/T6)

Study design

Randomised double-blind dietary cross-over intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Blood indices, intestinal microflora

Intervention

The consumption once a day 150 g of probiotic yoghurt versus regular yoghurt for 3 weeks. Probiotic yoghurt containing either Lactobacillus plantarum strain 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. Fasting blood samples are collected.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The health indices of study participants (eight, weight, body mass index, blood pressure) assessed at the recruitment, after 3 weeks of probiotic treatment, after washout and after 3-week placebo treatment
2. The self-reported questionnaire containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial
3. Haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, hs-CRP and IL-6 measured at the recruitment, after 3 weeks of probiotic treatment, after washout and after 3-week placebo treatment

Secondary outcome measures

Circulation of polyamines in host

Overall trial start date

07/02/2011

Overall trial end date

04/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Wish to participate in the study
2. Aged 18 years and over, either sex
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

100 persons of both sexes, 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

07/02/2011

Recruitment end date

04/04/2011

Locations

Countries of recruitment

Estonia

Trial participating centre

Ravila 19
Tartu
50411
Estonia

Sponsor information

Organisation

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

Sponsor details

Kreutzwaldi 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 LLC (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