Clinical trial NCT06108505: A Clinical Study on the Effectiveness of a Lacticaseibacillus Strain on Blood Cholesterol Levels
Official title: A Prospective, Multicentre, Randomised Clinical Study Evaluating the Effectiveness of Lacticaseibacillus Wild Type Strain on Lowering Blood Cholesterol Levels
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cholesterol Levels
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: LDL-c levels up to 10 weeks
timeFrame: At 10 weeks after treatment initiation
Secondary outcomes:
measure: LDL-c levels up to 12 weeks
timeFrame: At 6 and 12 weeks after treatment initiation
measure: HDL-c, total cholesterol, and TG levels measurement
timeFrame: At 6, 10 and 12 weeks after treatment initiation
measure: Changes in SCORE 2 levels
timeFrame: At 10 weeks after treatment initiation
measure: Subjects adherence to study
timeFrame: Up to 10 weeks
measure: Serious adverse events evaluation
timeFrame: Up to 12 weeks after treatment initiation
Other outcomes:
measure: Changes in VAS scale
timeFrame: At 6, 10 and 12 weeks
measure: Changes in serum levels
timeFrame: At 6, 10 and 12 weeks
measure: Changes in LDL-c, HDL-c, total cholesterol, and TG
timeFrame: Up to 12 weeks
Locations:
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: East Macedonia And Thrace
Study officials:
affiliation: Democritus University of Thrace
name: Yiannis Kourkoutas
role: STUDY_DIRECTOR
References: