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

Democritus University of Thrace60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Cholesterol Levels

Interventions

Lacticaseibacillus with oatsOTHER

Subjects will receive 7.5 gr of oats containing Lacticaseibacillus

Plain oatsOTHER

Subjects will receive 7.5 gr of plain oats

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult participants of either sex with ages between 18 and 70 years (limits included). 2. Participants with serum LDL-C ≥116 mg/dl. 3. Body Mass Index (BMI) between 18.5 and 35 kg/m2 (limits excluded). Exclusion Criteria: 1. 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. 2. 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. 3. Lactating females or those that are planning pregnancy within 6 months from the start of the study. 4. 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. 5. 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. 6. Subjects with a known intolerance or allergy to any ingredient of the administered products. 7. 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. 8. Participants who are receiving any interventional procedure or are currently included in a clinical study.

Locations (1)

Democritus University of Thrace

Alexandroupoli, East Macedonia and Thrace, Greece

Outcomes

Primary Outcomes

LDL-c levels up to 10 weeks

Change in LDL-c levels from baseline at 10 weeks

Time frame: At 10 weeks after treatment initiation

Secondary Outcomes

LDL-c levels up to 12 weeks

Change in LDL-c levels from baseline at 6 and 12 weeks

Time frame: 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

Time frame: At 6, 10 and 12 weeks after treatment initiation

Changes in SCORE 2 levels

Change in SCORE2 risk level from baseline at 10 weeks

Time frame: 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

Time frame: Up to 10 weeks

Serious adverse events evaluation

The number, type, severity, and seriousness of adverse events related to the study product

Time frame: Up to 12 weeks after treatment initiation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.