Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/10/2014
Date assigned
12/03/2015
Last edited
10/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tiiu Kullisaar

ORCID ID

Contact details

Ravila str 19
Dept Biochemistry
Tartu
50411
Estonia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

237/M-15

Study information

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

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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

10/10/2014

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 50

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

Locations

Countries of recruitment

Estonia

Trial participating centre

Ravila str 19, Dept Biochemistry
Tartu
50411
Estonia

Sponsor information

Organisation

GIE Eurasanté (France)

Sponsor details

310 rue Eugene Avinee
Loos-lez-Lille
59120
France

Sponsor type

Research organisation

Website

Funders

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

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