A Clinical Study on the Effectiveness of a Lacticaseibacillus Strain on Blood Cholesterol Levels

Study Overview
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Brief Summary
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This is a 12-week prospective, multicentre, randomised Phase 4 study to evaluate the effect of a wild type strain of Lacticaseibacillus in cholesterol of blood levels.

Detailed Description
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The goal of this study is to evaluate the effect of a wild type strain of Lacticaseibacillus as an incorporated ingredient of oat powder in the improvement of low density lipoprotein levels. In the study will participate two groups of subjects, one group with receive the strain with oats for 2.5 months and the other a group of subjects will receive plain oats. During the study, the subjects will receive only the product of the study and no other intervention will be performed except the standard clinical practice. The subjects will perform 4 visits and their eligibility will be evaluated at the baseline visit by performing routine clinical and laboratory examinations. The subjects who will consent to participate in the study will be randomised 1:1 into one of the study arms (Lacticaseibacillus and oats vs. oats). At each follow-up visit, the standard clinical and laboratory tests for dyslipidemia will be performed at the hospital. Following a treatment period of 10 weeks, a 2-week washout observational period will take place where subjects will not receive any product.

Official Title
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A Prospective, Multicentre, Randomised Clinical Study Evaluating the Effectiveness of Lacticaseibacillus Wild Type Strain on Lowering Blood Cholesterol Levels

Conditions
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Cholesterol Levels

Intervention / Treatment
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* Other: Lacticaseibacillus with oats
* Other: Plain oats


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants of either sex with ages between 18 and 70 years (limits included). Participants with serum LDL-C ≥116 mg/dl. Body Mass Index (BMI) between 18.5 and 35 kg/m2 (limits excluded). Exclusion Criteria: Subjects who systematically receive any other lipid-lowering non-medicinal product, supplement or functional food such as ACTIMEL, ACTIVIA, oat beta-glucan, pharmaceutical garlic, or stopped less than 1 month prior to study inclusion. Participants that have been under lipid-lowering drug treatment (e.g. statins, fibrates, etc.) or any other medication that has a significant effect on LDL-c within the last 2 months prior to study inclusion. Lactating females or those that are planning pregnancy within 6 months from the start of the study. Participants with a history of ischemic cardiovascular events, alcohol abuse, or suffering from a severe chronic disease (e.g. cancer, diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, cancer, familial hypercholesterolemia or immunosuppression) that would potentially affect the outcomes of the study. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial. Subjects with a known intolerance or allergy to any ingredient of the administered products. Participants who are planning on making significant changes in their diet, lifestyle, and physical activity during the duration of the study, i.e. participants that are currently on weight-reducing diets. Participants who are receiving any interventional procedure or are currently included in a clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 1:1 randomization will be used in the study to allocate subjects into two groups. A group will receive the strain of Lacticaseibacillus with oats and the other group will receive only plain oats.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacticaseibacillus with oats<br>This group of subjects receives the Lacticaseibacillus with oats. | Other: Lacticaseibacillus with oats<br>* Subjects will receive 7.5 gr of oats containing Lacticaseibacillus<br>|
| Placebo Comparator: Plain oats<br>This group of subjects receives plain oats. | Other: Plain oats<br>* Subjects will receive 7.5 gr of plain oats<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-c levels up to 10 weeks | Change in LDL-c levels from baseline at 10 weeks | At 10 weeks after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-c levels up to 12 weeks | Change in LDL-c levels from baseline at 6 and 12 weeks | At 6 and 12 weeks after treatment initiation | 
| HDL-c, total cholesterol, and TG levels measurement | Change in HDL-c, total cholesterol, and TG levels from baseline at 6, 10, and 12 weeks | At 6, 10 and 12 weeks after treatment initiation | 
| Changes in SCORE 2 levels | Change in SCORE2 risk level from baseline at 10 weeks | At 10 weeks after treatment initiation | 
| Subjects adherence to study | The percentage of participants that are adherent to receiving the study product, defined as receiving ≥80% off suggested doses at 10 weeks | Up to 10 weeks | 
| Serious adverse events evaluation | The number, type, severity, and seriousness of adverse events related to the study product | Up to 12 weeks after treatment initiation |