The effects of Lactobacillus plantarum INDUCIA® probiotic in healthy volunteers with elevated cholesterol
| ISRCTN | ISRCTN11616457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11616457 |
| Secondary identifying numbers | IND1 |
- Submission date
- 04/10/2022
- Registration date
- 13/01/2023
- Last edited
- 08/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Mortality from cardiovascular disease is the world leader. In order to reduce the risk of cardiovascular disease, it is recommended to reduce the total serum cholesterol and LDL cholesterol as well as oxidative stress.
There is a focus on functional foods, including foods containing probiotics and food supplements. The positive effects of probiotics on lowering cholesterol and alleviating excessive oxidative stress have been described in scientific articles. Positive results have been obtained with various probiotics in reducing oxidative stress, an important factor for the pathogenesis of cardiovascular disease.
Probiotics are friendly bacteria that are known to improve health in human beings by, amongst other ways, interacting with the bacteria that already live in the gut. The aim of this study is to test if the daily consumption of a probiotic supplement can improve cholesterol metabolism, oxidative stress markers, clinical blood indices and gastrointestinal microbiota of reasonably healthy volunteers with elevated cholesterol.
Who can participate?
Generally healthy people aged between 30 and 65 years old with higher cholesterol levels
What does the study involve?
Participants will be randomly allocated to either a probiotic or a placebo group and asked to take one capsule per day for 12 weeks. Participants will also be asked to assess their well-being and gastrointestinal (digestive) effects, and also to provide blood, urine and fecal samples to test the effect of the probiotic.
What are the possible benefits and risks of participating?
A benefit of participation is that subjects will receive an assessment of their health status and if necessary recommendations for future steps. The study will cause minimal inconvenience to participants. As blood samples are taken by an experienced nurse, the procedure is safe. However, as with any blood test, there may be bruising and discomfort at the site of the blood test. The amounts of blood will be small enough not to cause fatigue or anemia.
Where is the study run from?
Laboratory for Clinical and Physiological Research, BioCC LLC (Estonia)
When is the study starting and how long is it expected to run for?
From January 2019 to December 2021
Who is funding the study?
BioCC LLC (Estonia)
Who is the main contact?
Ms. Merle Rätsep (Estonia)
Merle.ratsep@biocc.ee
Contact information
Scientific
Riia 181A
Tartu
50411
Estonia
| Phone | +372 53466569 |
|---|---|
| merle.ratsep@biocc.ee |
Study information
| Study design | Interventional randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Mechanisms of action of a probiotic strain Lactobacillus plantarum INDUCIA® DSM21379 comprising dietary supplement on cholesterol metabolism, oxidative stress markers, clinical blood indices, and gastrointestinal microbiota of reasonably healthy volunteers with elevated cholesterol |
| Study objectives | The consumption of a dietary supplement comprising L. plantarum INDUCIA® DSM21379 has a positive effect on any of the following health parameters of reasonably healthy volunteers with elevated cholesterol: cholesterol metabolism, oxidative stress markers, clinical blood indices, and gastrointestinal microbiota. |
| Ethics approval(s) | Approved 19/11/2018, Research Ethics Committee of the University of Tartu (University of Tartu, Grant Office, Lossi 3, 51003 Tartu, Estonia; +372 737 6215; eetikakomitee@ut.ee), ref: 287/T-24 |
| Health condition(s) or problem(s) studied | Elevated cholesterol levels |
| Intervention | Participants were randomly allocated to either the intervention group or the placebo group applying a 1:1 allocation ratio. Group 1 (verum): Participants take one capsule daily for twelve weeks. The capsule contains a daily dose of a product containing 5x10e9 CFU of L. plantarum INDUCIA®. Group 2 (placebo): Participants take one capsule daily for twelve weeks. The capsule contains a daily dose of a product containing no active compounds (microcellulose). Participants take the product daily for twelve weeks and the last study visit will be performed two weeks after the end of the treatment. All the samples are collected at the run-in, after 8 weeks and at the end of the interventions. Changes at 8 weeks from baseline and at 12 weeks from baseline are measured for the following outcomes: oxidative stress indices (ELISA), SCFA's content in faeces (HPLC), and changes in lipid fractions. |
| Intervention type | Supplement |
| Primary outcome measure | 1. LDL-cholesterol level in blood serum at baseline, and weeks 8, 12 and 14 2. Total-cholesterol level in blood serum at baseline, and weeks 8, 12 and 14 3. Oxidative stress indices measured from blood and urine samples using different ELISA-based assays at baseline, and weeks 8 and 12 4. Gut microflora indices (lactoflora, anaerobes etc) measured from stool samples using molecular approaches and specific primers at baseline, and weeks 8, 12 and 14 |
| Secondary outcome measures | 1. Metabolic syndrome indices measured from blood samples using different ELISA-based assays at baseline, and weeks 8 and 12 2. Short-chain fatty acids (SCFA) measured from stool and urine samples using High-Pressure Liquid Chromatography (HPLC) at baseline, and weeks 8, 12 and 14 3. Bile acids concentration measured from stool and urine samples High-Pressure Liquid Chromatography (HPLC) at baseline, and weeks 8, 12 and 14 |
| Overall study start date | 01/06/2018 |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 37 |
| Key inclusion criteria | 1. Written informed consent 2. Aged between 30 and 65 years old 3. Willingness to maintain a stable diet and physical activity level 4. Willingness to cease using probiotic products and supplements (except vitamin D) during the study period 5. Normal or not clinically relevant deviations in safety laboratory values 6. One of the following outcomes at the screening visit: LDL-cholesterol value >3.4 mmol/L; LDL-cholesterol/HDL-cholesterol >3.5 mmol/L or total cholesterol/HDL between 3.5 and 4.5 mmol/L |
| Key exclusion criteria | 1. Using blood pressure and/or cholesterol lowering drugs/supplements within the last 3 months prior to start of the study (i.e. baseline visit) 2. Diabetes 3. Acute or chronic inflammatory disease 4. Endocrinological disease 5. (Food) allergy 6. Using antibiotic within the last 4 weeks prior to start of the study (i.e. baseline visit) 7. Using NSAIDs regularly 8. Pregnancy and breastfeeding 9. Donor within the last 3 months prior to start of the study (i.e. baseline visit) 10. Smoking 11. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study 12. Intolerance to the investigational product/its ingredients 13. Acute infection within the last 2 weeks prior to baseline 14. Eating disorder 15. Extensive exercise (daily training of professional athletes) 16. Drug or alcohol abuse |
| Date of first enrolment | 03/01/2019 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- Estonia
Study participating centre
Tartu
50411
Estonia
Sponsor information
Industry
Kreutzwaldi 1
Tartu
51006
Estonia
| Phone | +372 516 4210 |
|---|---|
| ene.tammsaar@biocc.eu | |
| Website | https://www.biocc.eu |
"ROR" |
https://ror.org/02e801388 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to belonging to a private company. |
Editorial Notes
08/01/2024: The intention to publish date was changed from 30/06/2024 to 31/12/2024.
12/12/2022: Trial's existence confirmed by the Research Ethics Committee of the University of Tartu.
