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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cholesterol Levels
• Intervention / Treatment: Other: Lacticaseibacillus with oats; Other: Plain oats

Detailed Description

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
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • East Macedonia And Thrace
    • Alexandroupolis, East Macedonia And Thrace, Greece, 68100
      • Democritus University of Thrace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in VAS scale	Change in 11-point Visual Activity Score (VAS) from baseline on the overall satisfaction with bowel symptoms and Bristol Stool scale at 6, 10, and 12 weeks.	At 6, 10 and 12 weeks
Changes in serum levels	Change in the serum levels, compared to baseline, of glucose, creatinine, urea, AST, ALT, γGT, ALP, LDH, hsCRP, and Lp(a), ΑpoA1, ApoB, Homocysteine, vitD as optional, where available, at 6, 10, and 12 weeks	At 6, 10 and 12 weeks
Changes in LDL-c, HDL-c, total cholesterol, and TG	Change in LDL-c, HDL-c, total cholesterol, and TG at each visit compared to levels within 3 months before study inclusion, where available, and for patients who did not receive any therapeutic or lifestyle interventions during that time	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Study Director: Yiannis Kourkoutas, Democritus University of Thrace

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2022
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CLASSIC study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregates results can be available for GDPR reasons

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No