Effect of novel probiotic food supplement on elevated cardiometabolic and inflammatory markers on clinically asymptomatic volunteers.

Plain English Summary

Background and study aims
Reg’Activ Cholesterol is a food supplement containing the probiotic lactobacillus fermentation ME-3. This probiotic is an antioxidant that has been shown to reduce oxidative stress, inflammation and cholesterol and has beneficial effects on blood glucose levels. The aim of this study is further to investigate further the effects of the Reg’Activ Cholesterol.

Who can participate?
Adults without clinical health problems, aged between 40-70 years and with high blood triglyceride and cholesterol levels

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (experimental group) are given Reg’Activ Cholesterol capsules for 8 weeks. Those in group 2 (control) are given a placebo for 8 weeks. Blood samples are taken from all participants at the start of the study and then after 4 and 8 weeks. These samples are analysed for blood cholesterol, triglyceride, and glucose levels and also for biomarkers of inflammation.

What are the possible benefits and risks of participating?
The benefit of participating in this study is that it may have health benefits for participants. There are no expected risks in participating. There is a small risk of bruising from giving a blood sample.

Where is the study run from?
University of Tartu (Estonia)

When is the study starting and how long is it expected to run for?
October 2014 to March 2015.

Who is funding the study?
1. University of Tartu, Faculty of Medicine, Department of Biochemistry (Estonia)
2. GIE Eurasante (France)

Who is the main contact?
1. Professor Mihkel Zilmer (University of Tartu)
2. Professor Tiiu Kullisaar (University of Tartu)

Study website

Type

Scientific

Contact name

Dr Tiiu Kullisaar

ORCID ID

Contact details

Ravila str 19
Dept Biochemistry
Tartu
50411
Estonia

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Secondary identifying numbers

237/M-15

Scientific title

Effect of novel probiotic food supplement on elevated cardiometabolic and inflam¬matory markers on clinically asymptomatic volunteers (a randomized blinded study).

Acronym

Study hypothesis

The consumption of novel probiotic food supplement (Reg’Activ Cholesterol) compromising L. fermentum strain ME-3 helps to improve serum cardiometabolic and inflammatory markers.

Ethics approval(s)

Human Research Ethics Review Committee, University of Tartu, 19/05/2014, ref: 237/M-15

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Treatment

Patient information sheet

A written informed consent

Condition

Elevated values of blood lipids, oxidative stress, inflammation and blood glucose related indices.

Intervention

The consumption of a food supplement Reg’Activ Cholesterol: daily dose two capsules for 4 and 8 weeks vs consumption of control capsules

Intervention type

Supplement

Primary outcome measure

1. LDL cholesterol
2. Triglycerides
3. Glycated hemoglobin
4. Oxidized LDL
5. Isoprostanes
Measured at baseline, at 4th week from the beginning of the trial, 8th week from the beginning of the trial.

Secondary outcome measures

1. HsCRP
2. Homocysteine
3. IL-6
4. TG/HDL ratio
5. Oxidative stress index
6. Proinflammatory cytokines
7. Adiponectin
8. Antiinflammatory cytokines
Measured at baseline, at 4th week from the beginning of the trial, 8th week from the beginning of the trial.

Overall study start date

10/10/2014

Overall study end date

31/03/2015

Reason abandoned (if study stopped)

Participant inclusion criteria

1. A written informed consent
2. Aged between 40 - 70 years
3. No known health problems
4. Total cholesterol higher than 5.3 mmol/L or LDL-chol higher than 3.0mmol/L or triglycerides higher than 1.7 mmol/L or total cholesterol/HDL higher than 4 or LDL/HDL higher than 3 or glycated Hb higher than 5.7% or hsCRP higher than 1,0 mg/L or homocysteine higher than 11 micromol/L
5. 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), supplementation with e.g. omega-3 fatty acids, calcium, oat fiber, niacin, green tea extract, plant sterols, vitamins, soy protein, psyllium seed husk or probiotics/prebiotics within the preceding at least 3 weeks
6. Willingness to maintain a stable diet and physical activity level

Participant type(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

At least 50

Total final enrolment

45

Participant exclusion criteria

1. Pregnancy and breastfeeding
2. History of gastrointestinal disease
3. Food allergy
4. Diabetes
5. Acute infection within the last 3 weeks prior to enrolment
6. Use of any antimicrobial agents within the preceding 2 months
7. Use of any regular concomitant medication including any non-steroidal anti-inflammatory drugs and antioxidant products 3 weeks
8. Intolerance to the investigational product / its ingredients
9. Any kind of concurrent disease which could influence the evaluation of the efficacy
10. Tolerability of the investigational study product
11. Any serious organ or systemic diseases
12. Eating disorder
13. Extensive exercise
14. Genetic hyperlipidemia
15. Drug or alcohol abuse
16. Active weight loss > 5 kg in prior 3 months participation in other studies within the last 30 days /
during the study

Recruitment start date

10/10/2014

Recruitment end date

31/03/2015

Countries of recruitment

Estonia

Study participating centre

Ravila str 19, Dept Biochemistry
Tartu
50411
Estonia

Organisation

GIE Eurasanté (France)

Sponsor details

310 rue Eugene Avinee
Loos-lez-Lille
59120
France

Sponsor type

Research organisation

Website

ROR

https://ror.org/0165tjs71

Funder type

University/education

Funder name

University of Tartu, Faculty of Medicine, Department of Biochemistry (Estonia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

GIE Eurasanté (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

2018 abstract in https://www.longdom.org/proceedings/complex-approach-to-cardiovascular-risk-profile-with-a-food-supplement-41665.html

Intention to publish date

Individual participant data (IPD) Intention to share

No

IPD sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs