A Clinical Study on the Effectiveness of a Lacticaseibaci... | NCT06108505

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

NCT06108505

Sponsor

Democritus University of Thrace

Status

Unknown status

Last Update Posted

Oct 31, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Cholesterol Levels

Interventions

Lacticaseibacillus with oats
Plain oats

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2022Actual

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Nov 2023Estimated

First Submitted Date

Oct 25, 2023

First Submission Date that Met QC Criteria

Oct 25, 2023

First Posted Date

Oct 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2023

Last Update Posted Date

Oct 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lacticaseibacillus with oats	Experimental	This group of subjects receives the Lacticaseibacillus with oats.	Other: Lacticaseibacillus with oats
Plain oats	Placebo Comparator	This group of subjects receives plain oats.	Other: Plain oats

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lacticaseibacillus with oats	Other	Subjects will receive 7.5 gr of oats containing Lacticaseibacillus	Lacticaseibacillus with oats

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yiannis Kourkoutas	Democritus University of Thrace	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Democritus University of Thrace		Alexandroupoli	East Macedonia and Thrace	68100	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Only aggregates results can be available for GDPR reasons

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided