Cholesterol Levels
Conditions
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.
Interventions
OTHERLacticaseibacillus with oats
Subjects will receive 7.5 gr of oats containing Lacticaseibacillus
OTHERPlain oats
Subjects will receive 7.5 gr of plain oats
Sponsors
Democritus University of Thrace
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither participant nor site investigator is aware for the product
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-c levels up to 10 weeks | At 10 weeks after treatment initiation | Change in LDL-c levels from baseline at 10 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL-c, total cholesterol, and TG levels measurement | At 6, 10 and 12 weeks after treatment initiation | Change in HDL-c, total cholesterol, and TG levels from baseline at 6, 10, and 12 weeks |
| Changes in SCORE 2 levels | At 10 weeks after treatment initiation | Change in SCORE2 risk level from baseline at 10 weeks |
| Subjects adherence to study | Up to 10 weeks | The percentage of participants that are adherent to receiving the study product, defined as receiving ≥80% off suggested doses at 10 weeks |
| Serious adverse events evaluation | Up to 12 weeks after treatment initiation | The number, type, severity, and seriousness of adverse events related to the study product |
| LDL-c levels up to 12 weeks | At 6 and 12 weeks after treatment initiation | Change in LDL-c levels from baseline at 6 and 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in LDL-c, HDL-c, total cholesterol, and TG | Up to 12 weeks | 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 |
| Changes in serum levels | At 6, 10 and 12 weeks | 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 |
| Changes in VAS scale | At 6, 10 and 12 weeks | 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. |
Countries
Greece
Outcome results
None listed