Effect of probiotic yoghurt on the blood cholesterol levels of healthy volunteers

ISRCTN ISRCTN12076381
DOI https://doi.org/10.1186/ISRCTN12076381
Secondary identifying numbers JOG5/1
Submission date
17/11/2021
Registration date
30/12/2021
Last edited
20/12/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Hypercholesterolemia (the presence of high levels of cholesterol in the blood) is one of the risk factors for cardiovascular diseases (CVD) and oxidized LDL (oxLDL) has been shown to play an important role in atherosclerosis (narrowing of the arteries). The cholesterol threat to health has grown out of dietary changes in developed countries, with increasing consumption of saturated fats, to which the human body has been unable to fully adapt. There is strong evidence that a reduction of LDL-cholesterol and oxLDL by dietary changes would generally reduce the risk of CVD, particularly coronary heart disease.
The consumption of fermented milk products containing health beneficial probiotic lactic acid bacteria may help to prevent CVD by eliminating various risk factors, including high cholesterol levels. The aim of this study is to assess the effectiveness of probiotic yoghurt on lowering blood cholesterol, especially oxLDL.

Who can participate?
Generally healthy adults aged 18 to 65 years with elevated LDL-cholesterol levels who do not take medication.

What does the study involve?
Participants are randomly allocated into two groups: one group will consume a probiotic yoghurt daily for 8 weeks while the other group will consume a non-probiotic yoghurt daily for 8 weeks. Participants are asked to assess their well-being and gastrointestinal (digestive) effects, but also to provide blood, urine and fecal samples to test the effect of the probiotic.

What are the possible benefits and risks of participating?
The study causes minimal inconvenience to participants. As blood samples are taken by an experienced nurse, the procedure is safe. However, there may be bruising and discomfort at the site of the blood test as with any blood test. The amounts of blood taken are small enough that they should not make participants feel fatigue or cause anemia. There may be local red reactions at the site of the injections. Participants will receive an assessment of their health status and if necessary, a free consultation with a nutritionist and/or a specialist.

Where is the study run from?
The study was carried out in cooperation between the Bio-Competence Centre of Healthy Dairy Products LLC, the Faculty of Medicine, University of Tartu and the Maag Dairy Industry Ltd (Estonia). The study took place at the Bio-Competence Centre of Healthy Dairy Products LLC in Tartu (Estonia).

When is the study starting and how long is it expected to run for?
February 2014 to April 2015

Who is funding the study?
BioCC OÜ (Estonia)

Who is the main contact?
Merle Rätsep (researcher)
merle.ratsep@biocc.ee

Contact information

Miss Merle Rätsep
Scientific

Riia 181A
Tartu
50411
Estonia

Phone +372 (0)53466569
Email merle.ratsep@biocc.ee

Study information

Study designDouble-blind placebo-controlled (DBPC) parallel-designed two-armed randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleEffect of yoghurt containing Lactobacillus plantarum Inducia on level of oxLDL-cholesterol and on some oxidative stress related indices of healthy volunteers
Study acronymJOG5
Study objectivesConsumption of yoghurt containing L. plantarum Inducia contributes to the protection of blood lipids (especially low-density lipoprotein [LDL] particles) from oxidative damage.
Ethics approval(s)Approved 15/10/2014, Ethics Review Committee on Human Research of the University of Tartu (Raekoja plats 9, 51004, Tartu, Estonia; +372 (0)737 6215; eetikakomitee@ut.ee), ref: 240/T-11
Health condition(s) or problem(s) studiedElevated LDL cholesterol levels
InterventionParticipants are randomly allocated to one of two groups. Randomisation is prepared by a study statistician using statistical analysis software and participants are randomly allocated to one of the treatment groups (placebo or verum) applying a 1:1 allocation ratio.

Participants consume a daily dose of a probiotic yoghurt (150 g) containing Lactobacillus plantarum strain INDUCIA (2x10e9 colony-forming units [CFU]) for 8 weeks, or a control yoghurt (150 g).
Intervention typeSupplement
Primary outcome measureBlood oxLDL-cholesterol level measured using blood tests (ELISA) at baseline and weeks 8
Secondary outcome measures1. ox-LDL values measured using blood tests (ELISA) at baseline and weeks 4
2. Total cholesterol, LDL-cholesterol, non-HDL-cholesterol measured by standard laboratory methods in the United Laboratories of Tartu University Hospital (Estonia) from fasting blood serum at baseline, weeks 4 and weeks 8
3. Blood oxidative stress indices measured from blood serum by ELISA at baseline, weeks 4 and weeks 8
Overall study start date02/02/2014
Completion date01/04/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants250
Total final enrolment132
Key inclusion criteria1. A written informed consent
2. Aged between 18 - 65 years
3. No personally known health problems
4. No use of any concomitant treatment which could influence the evaluation of the efficacy and the tolerability of the investigational study product, including lipid-lowering drugs (e.g., statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid) within the preceding 2 months
6. Willingness to maintain a stable diet and physical activity level
7. Normal or not clinically pronounced safety lab values (clinical chemistry, blood count)
8. LDL-cholesterol values ≥3.0 mmol/l– 5.3 mmol/l
Key exclusion criteria1. Pregnancy and breastfeeding
2. A history of gastrointestinal disease, food allergy, diabetes and acute infection within the last 2 weeks prior to enrolment
3. Use of any antimicrobial agents within the preceding 2 months or use of any regular concomitant medication including any non-steroidal anti-inflammatory drugs and antioxidant products 2 weeks
4. Intolerance to the investigational product/its ingredients
5. Any kind of concurrent disease which could influence the evaluation of the efficacy and the tolerability of the investigational study product
6. Any serious organ or systemic diseases
7. High blood pressure (e.g., >140/95 mmHg)
8. Eating disorder
9. Extensive exercise
10. Genetic hyperlipidemia
11. Drug or alcohol abuse
12. Active weight loss >5 kg in prior 3 months
13. Participation in other studies within the last 30 days/during the study
Date of first enrolment17/10/2014
Date of final enrolment04/02/2015

Locations

Countries of recruitment

  • Estonia

Study participating centre

Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)
Kreutzwaldi 1
Tartu
51014
Estonia

Sponsor information

BioCC OÜ
Industry

Kreutzwaldi 1
Tartu
51014
Estonia

Phone +372 (0)53466569
Email ene.tammsaar@biocc.ee
Website https://www.biocc.eu

Funders

Funder type

Government

European Regional Development Fund under Project EU30002 of the BioCC OÜ
Government organisation / National government
Alternative name(s)
Europski Fond za Regionalni Razvoj, Den Europæiske Fond for Regionaludvikling, Europees Fonds voor Regionale Ontwikkeling, Euroopa Regionaalarengu Fond, Fonds Européen de Développement Régional, Europäischer Fonds für regionale Entwicklung, Európai Regionális Fejlesztési Alap, Fondo Europeo di Sviluppo Regionale, Eiropas Reģionālās attīstības fonds, Europos Regionines Pletros Fondas, Europejski Fundusz Rozwoju Regionalnego, Fundo Europeu de Desenvolvimento Regional, Fondul European de Dezvoltare Regională, Európsky Fond Regionálneho Rozvoja, Fondo Europeo de Desarrollo Regional, Европейски фонд за регионално развитие, Evropský fond pro regionální rozvoj, Ευρωπαϊκό Ταμείο Περιφερειακής Ανάπτυξης, Il-Fond Ewropew għall-Iżvilupp Reġjonali, Evropski sklad za regionalni razvoj, Euroopan aluekehitysrahasto, Europeiska regionala utvecklingsfonden, ERDF, FEDER, EFRE, ЕФРР, EFRR, EFRU, ERFi, ΕΤΠΑ, FEDER, FESR, ERAF, ERPF, ERFA, L-FEŻR, EFRO, EFRR, FEDR, ESRR, EAKR, Eruf

Results and Publications

Intention to publish date31/01/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 28/11/2022 20/12/2022 Yes No

Editorial Notes

20/12/2022: Publication reference added.
07/02/2022: The sponsor organisation has been changed from "BioCC" to "BioCC OÜ".
08/12/2021: Trial's existence confirmed by the Ethics Review Committee on Human Research of the University of Tartu.