Cholesterol LevelsNCT06108505
A Clinical Study on the Effectiveness of a Lacticaseibacillus Strain on Blood Cholesterol Levels
A study testing Lacticaseibacillus with oats and Plain oats in people with Cholesterol Levels, run by Democritus University of Thrace at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholesterol Levels
- What is being tested?
- Lacticaseibacillus with oats and Plain oats
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 4 Dec 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Democritus University of Thrace
Alexandroupoli, East Macedonia and Thrace, 68100
About this study
Official title: A Prospective, Multicentre, Randomised Clinical Study Evaluating the Effectiveness of Lacticaseibacillus Wild Type Strain on Lowering Blood Cholesterol Levels
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.
Read the 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
- Being tested
- Lacticaseibacillus with oats, Plain oats
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus with oatsOther
Subjects will receive 7.5 gr of oats containing Lacticaseibacillus
Plain oatsOther
Subjects will receive 7.5 gr of plain oats
| Study group | Role | What they receive |
|---|---|---|
| Lacticaseibacillus with oats | Experimental | This group of subjects receives the Lacticaseibacillus with oats. Receives: Other: Lacticaseibacillus with oats |
| Plain oats | Placebo comparator | This group of subjects receives plain oats. Receives: Other: Plain oats |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-c levels up to 10 weeks
Change in LDL-c levels from baseline at 10 weeks
Measured: At 10 weeks after treatment initiation
Secondary outcomes (5)
LDL-c levels up to 12 weeks
Change in LDL-c levels from baseline at 6 and 12 weeks
Measured: 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
Measured: At 6, 10 and 12 weeks after treatment initiation
Changes in SCORE 2 levels
Change in SCORE2 risk level from baseline at 10 weeks
Measured: At 10 weeks after treatment initiation
Subjects adherence to study
The percentage of participants that are adherent to receiving the study product, defined as receiving ≥80% off suggested doses at 10 weeks
Measured: Up to 10 weeks
Serious adverse events evaluation
The number, type, severity, and seriousness of adverse events related to the study product
Measured: Up to 12 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start4 Dec 2022
- Primary completion31 Oct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiannis Kourkoutas, Democritus University of Thrace
- Investigators
- Yiannis Kourkoutas, Study director, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108505
- Sponsor's protocol ID
- CLASSIC study
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregates results can be available for GDPR reasons
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Randomised Clinical Study Evaluating the Effectiveness of Lacticaseibacillus Wild Type Strain on Lowering Blood Cholesterol Levels
- ClinicalTrials.gov ID
- NCT06108505
- Acronym / sponsor ID
- CLASSIC study
- Conditions
- Cholesterol Levels
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lacticaseibacillus with oats | Experimental | Other: Lacticaseibacillus with oatsThis group of subjects receives the Lacticaseibacillus with oats. |
| Plain oats | Placebo comparator | Other: Plain oatsThis group of subjects receives plain oats. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacticaseibacillus with oatsSubjects will receive 7.5 gr of oats containing Lacticaseibacillus | Other | Lacticaseibacillus with oats |
| Plain oatsSubjects will receive 7.5 gr of plain oats | Other | Plain oats |
Primary outcome
LDL-c levels up to 10 weeks
Time frame: At 10 weeks after treatment initiation
Change in LDL-c levels from baseline at 10 weeks
5 secondary outcomes
LDL-c levels up to 12 weeks
Time frame: At 6 and 12 weeks after treatment initiation
HDL-c, total cholesterol, and TG levels measurement
Time frame: At 6, 10 and 12 weeks after treatment initiation
Changes in SCORE 2 levels
Time frame: At 10 weeks after treatment initiation
Subjects adherence to study
Time frame: Up to 10 weeks
Serious adverse events evaluation
Time frame: Up to 12 weeks after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No. Only aggregates results can be available for GDPR reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiannis Kourkoutas study director
Democritus University of Thrace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacticaseibacillus with oats and Plain oats in people with Cholesterol Levels, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-c levels up to 10 weeks (time frame: At 10 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.