NCT06108505

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholesterol Levels

Interventions

Type	Name	Description
OTHER	Lacticaseibacillus with oats	Subjects will receive 7.5 gr of oats containing Lacticaseibacillus
OTHER	Plain oats	Subjects will receive 7.5 gr of plain oats

Timeline

• Start date: 2022-12-04
• Primary completion: 2023-10-31
• Completion: 2023-11-01
• First posted: 2023-10-31
• Last updated: 2023-10-31

Locations

1 site across 1 country: Greece