Effect of novel probiotic food supplement on elevated cardiometabolic and inflammatory markers on clinically asymptomatic volunteers.
| ISRCTN | ISRCTN55339917 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55339917 |
| Secondary identifying numbers | 237/M-15 |
- Submission date
- 30/10/2014
- Registration date
- 12/03/2015
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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)
Contact information
Scientific
Ravila str 19, Dept Biochemistry
Tartu
50411
Estonia
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | A written informed consent |
| Scientific title | Effect of novel probiotic food supplement on elevated cardiometabolic and inflam¬matory markers on clinically asymptomatic volunteers (a randomized blinded study). |
| Study hypothesis | The consumption of novel probiotic food supplement (RegActiv 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 |
| Condition | Elevated values of blood lipids, oxidative stress, inflammation and blood glucose related indices. |
| Intervention | The consumption of a food supplement RegActiv 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | At least 50 |
| Total final enrolment | 45 |
| 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 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
Study participating centre
50411
Estonia
Sponsor information
Research organisation
310 rue Eugene Avinee
Loos-lez-Lille
59120
France
"ROR" |
https://ror.org/0165tjs71 |
|---|
Funders
Funder type
University/education
No information available
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 2018 abstract in https://www.longdom.org/proceedings/complex-approach-to-cardiovascular-risk-profile-with-a-food-supplement-41665.html |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/10/2016 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
24/07/2020: Link to abstract added.
