Effect of probiotic yoghurt (L. plantarum strain TENSIA) on healthy volunteers

ISRCTN	ISRCTN31663396
DOI	https://doi.org/10.1186/ISRCTN31663396
Secondary identifying numbers	200-T4 from 17/01/2010

Submission date: 24/01/2011
Registration date: 21/06/2011
Last edited: 07/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika MIkelsaar
Scientific

Ravila 19
Tartu
50411
Estonia

Email	marika.mikelsaar@ut.ee

Study information

Study design	Randomised double-blind cross-over intervention study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
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 yoghurt comprising L. plantarum strain TENSIA on blood indices and intestinal microflora of healthy volunteers: A randomised controlled crossover trial
Study acronym	JOG3
Study objectives	The consumption of yoghurt containing probiotic L. plantarum strain TENSIA has positive impact on blood indices of healthy volunteers.
Ethics approval(s)	Ethics Review Committee on Human Research of the University of Tartu approved on the 17th January 2010 (ref: 200-T4)
Health condition(s) or problem(s) studied	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 TENSIA (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
Primary outcome measure	1. The health indices of study participants (height, 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, low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, high sensitivity C reactive protein (hs-CRP) and interlukin (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, oxidised low density lipoprotein (oxLDL), 8-isoprostanes, adiponectine, leptin, cytokines and growth factors (IL1 alfa, IL1beta, IL2, IL4, IL6, IL8, IL10, VEGF, EDG, ITFgamma, TNFalfa, MCP-1), osteoprotegerin
Overall study start date	07/02/2011
Completion date	04/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100 persons of both sexes, divided into in two groups
Key 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
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
Date of first enrolment	07/02/2011
Date of final enrolment	04/04/2011

Locations

Countries of recruitment

Estonia

Study participating centre

Ravila 19

Tartu
50411
Estonia

Sponsor information

BioCC OÜ
Hospital/treatment centre

Kreutzwaldi 1
Tartu
51014
Estonia

Phone	+372 (0)731 3411
Email	ene.tammsaar@tptak.ee
Website	http://www.tptak.ee

Funders

Funder type

Industry

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

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	Not provided at time of registration

Editorial Notes

07/02/2022: The sponsor organisation has been changed from "Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)" to "BioCC OÜ".