Status:
UNKNOWN
A Clinical Study on the Effectiveness of a Lacticaseibacillus Strain on Blood Cholesterol Levels
Lead Sponsor:
Democritus University of Thrace
Conditions:
Cholesterol Levels
Eligibility:
All Genders
18-70 years
Phase:
NA
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 st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06108505
Start Date
December 4 2022
End Date
November 1 2023
Last Update
October 31 2023
Active Locations (1)
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1
Democritus University of Thrace
Alexandroupoli, East Macedonia and Thrace, Greece, 68100