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

NCT06108505 | Unknown

• 1 other identifier: CLASSIC study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol Levels

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• LDL-c levels up to 12 weeks

  At 6 and 12 weeks after treatment initiation

• HDL-c, total cholesterol, and TG levels measurement

  At 6, 10 and 12 weeks after treatment initiation

• Changes in SCORE 2 levels

  At 10 weeks after treatment initiation

• Subjects adherence to study

  Up to 10 weeks

• Serious adverse events evaluation

  Up to 12 weeks after treatment initiation

Other Outcomes (3)

• Changes in VAS scale

  At 6, 10 and 12 weeks

• Changes in serum levels

  At 6, 10 and 12 weeks

• Changes in LDL-c, HDL-c, total cholesterol, and TG

  Up to 12 weeks

Study Arms (2)

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

Lacticaseibacillus with oats OTHER

Subjects will receive 7.5 gr of oats containing Lacticaseibacillus

Lacticaseibacillus with oats

Plain oats OTHER

Subjects will receive 7.5 gr of plain oats

Plain oats

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Democritus University of Thrace

Alexandroupoli, East Macedonia and Thrace, 68100, Greece

Location

Study Officials

• Yiannis Kourkoutas

  Democritus University of Thrace

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither participant nor site investigator is aware for the product
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory of Applied Microbiology & Biotechnology

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: December 4, 2022
• Primary Completion: October 31, 2023
• Study Completion: November 1, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)