HypercholesterolemiaNCT04677335
Combination of AB-LIFE Probiotic Plus Monacolin K to Reduce Blood Cholesterol
A study testing AB-LIFE with Monacolin K in people with Hypercholesterolemia, run by AB Biotics, SA.
Trial summary
This randomized study evaluates the effectiveness of a nutraceutical combining billion colony forming units (cfu) of three L. plantarum strains (CECT7527, CECT7528 and CECT7529) and 10 mg of monacolin K in reducing blood cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- AB-LIFE with Monacolin K
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 19 Sep 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Total cholesterol (TC) ≥200 mg/dL and statin-naïve or having recently stopped statin treatment because of statin intolerance.
Who cannot join
- History of cardiovascular events or alcohol abuse, presence of diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, familial hypercholesterolemia or immunosuppression
- Body mass index (BMI) ≤ 18.5 or ≥40 Kg/m2
- Use of antibiotics within 4 weeks of study initiation, current use of other probiotics, lipid-lowering medications, corticoids, beta-blockers or calcium channel blockers, thiazide diuretics, estrogen replacement therapy
- Pregnant or lactating women
- Patients with other severe disease that could interfere with the results of the study.
- Patients not agreeing to maintain their usual physical activity throughout the study.
About this study
Official title: Effect of a Nutritional Supplement (AB-LIFE Plus Monacolin K) to Reduce Total and LDL Cholesterol Levels
This randomized study evaluates the effectiveness of a nutraceutical combining billion colony forming units (cfu) of three L. plantarum strains (CECT7527, CECT7528 and CECT7529) and 10 mg of monacolin K in reducing blood cholesterol.
Read the detailed description
Cardiovascular diseases (CVDs) are the number 1 cause of death globally, and retention of low-density lipoprotein cholesterol (LDL-C) and similar cholesterol-rich lipoproteins containing apolipoprotein B (ApoB) within the arterial wall is a key initiating event in CVDs. Statins are the mainstay of pharmacological cholesterol-reduction therapy. However, a significant proportion of patients report some degree of statin intolerance, which typically fade away when the statin is switched, discontinued or the dosage reduced. A growing attention has been devoted to the correction of increased LDL-C levels through the use of dietary supplements, either because some patients have milder forms of hypercholesterolemia or as an alternative to statins in patients who may have experienced or are worried of side effects. Nutraceutical combinations are increasingly used in clinical practice. In this pilot randomized study, we sought to evaluate of the effect on LDL-C and other blood lipid parameters of a nutraceutical combining Red Yeast Rice extract (also known by its scientific name Monascus purpureus) containing 10 mg of monacolin K, plus 1 billion colony forming units (cfu) of the AB-LIFE probiotic formula. The later is composed of three L. plantarum strains, namely CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™).
- Conditions
- Hypercholesterolemia
- Being tested
- AB-LIFE with Monacolin K, Placebo
- Keywords
- Probiotic, Lactobacillus, Monacolin K, Monascus purpureus
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-LIFE with Monacolin KDietary supplement
Red yeast rice extract (also known by its scientific name, Monascus purpureus) certified to contain 10 mg of monacolin K, plus 1 billion total cfu of AB-LIFE probiotic formula, which is composed of 3 Lactoplantibacillus plantarum (formerly known as Lactobacillus plantarum) strains: CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™), all in a maltodextrin carrier. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).
PlaceboOther
Placebo capsules containing maltodextrin carrier only. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical | Experimental | Nutraceutical capsules taken once daily for 12 weeks Receives: Dietary Supplement: AB-LIFE with Monacolin K |
| Control | Placebo comparator | Placebo capsules taken once daily for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in low density lipoprotein cholesterol (LDL-C)
Fasting serum levels of low density lipoprotein cholesterol (LDL-C), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).
Measured: 0, 6 and 12 weeks
Secondary outcomes (8)
Change in total cholesterol (TC)
Fasting serum levels of total cholesterol (TC), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).
Measured: 0, 6 and 12 weeks
Change in high density lipoprotein cholesterol (HDL-C)
Fasting serum levels of high density lipoprotein cholesterol (HDL-C), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).
Measured: 0, 6 and 12 weeks
Change in triglycerides (TG)
Fasting serum levels of triglycerides (TG), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).
Measured: 0, 6 and 12 weeks
Change in Body Mass Index (BMI)
Body Mass Index, calculated as body weight (in kilograms) divided by squared height (in meters), assessed by repeated measures analysis at two timepoints (baseline and end of intervention).
Measured: 0 and 12 weeks
Change in body weight
Body weight in kilograms, assessed by repeated measures analysis at two timepoints (baseline and end of intervention).
Measured: 0 and 12 weeks
Change in percent body fat
Percent of body fat (as determined with a MC780 Body Analyzer), assessed by repeated measures analysis at two timepoints (baseline and end of intervention).
Measured: 0 and 12 weeks
Patient satisfaction with treatment
Rated with a Likert-type scale ranging 0 (very dissatisfied) to 4 (very satisfied), assessed at the end of the intervention.
Measured: 12 weeks
Treatment-emergent adverse effects
Incidence of adverse effects (type and number) and relatedness to study product (using a 5 category system: certain, likely related, possibly related, conditionally related, unknown), as documented according to the Spanish Medicine and Medical Device Agency (AEMPS) pharmacovigilance system
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Oct 2014
- Primary completion15 Apr 2016
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Extremadura
- Responsible party
- Sponsor
- Investigators
- Rafael Guerrero Bonmatty, PhD, Principal investigator, University of Extremadura (SPAIN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677335
- Sponsor's protocol ID
- PRIMACOL01
- Status last verified
- Jan 2021
- First submitted
- 27 Nov 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nutritional Supplement (AB-LIFE Plus Monacolin K) to Reduce Total and LDL Cholesterol Levels
- ClinicalTrials.gov ID
- NCT04677335
- Acronym / sponsor ID
- PRIMACOL01
- Conditions
- Hypercholesterolemia
- Keywords
- Probiotic, Lactobacillus, Monacolin K, Monascus purpureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- University of Extremadura
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 21 Dec 2020 (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 randomized study evaluates the effectiveness of a nutraceutical combining billion colony forming units (cfu) of three L. plantarum strains (CECT7527, CECT7528 and CECT7529) and 10 mg of monacolin K in reducing blood cholesterol.
Detailed description
Cardiovascular diseases (CVDs) are the number 1 cause of death globally, and retention of low-density lipoprotein cholesterol (LDL-C) and similar cholesterol-rich lipoproteins containing apolipoprotein B (ApoB) within the arterial wall is a key initiating event in CVDs. Statins are the mainstay of pharmacological cholesterol-reduction therapy. However, a significant proportion of patients report some degree of statin intolerance, which typically fade away when the statin is switched, discontinued or the dosage reduced. A growing attention has been devoted to the correction of increased LDL-C levels through the use of dietary supplements, either because some patients have milder forms of hypercholesterolemia or as an alternative to statins in patients who may have experienced or are worried of side effects. Nutraceutical combinations are increasingly used in clinical practice. In this pilot randomized study, we sought to evaluate of the effect on LDL-C and other blood lipid parameters of a nutraceutical combining Red Yeast Rice extract (also known by its scientific name Monascus purpureus) containing 10 mg of monacolin K, plus 1 billion colony forming units (cfu) of the AB-LIFE probiotic formula. The later is composed of three L. plantarum strains, namely CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical | Experimental | Dietary Supplement: AB-LIFE with Monacolin KNutraceutical capsules taken once daily for 12 weeks |
| Control | Placebo comparator | Other: PlaceboPlacebo capsules taken once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total cholesterol (TC) ≥200 mg/dL and statin-naïve or having recently stopped statin treatment because of statin intolerance.
Key exclusion criteria (6 listed)
- History of cardiovascular events or alcohol abuse, presence of diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, familial hypercholesterolemia or immunosuppression
- Body mass index (BMI) ≤ 18.5 or ≥40 Kg/m2
- Use of antibiotics within 4 weeks of study initiation, current use of other probiotics, lipid-lowering medications, corticoids, beta-blockers or calcium channel blockers, thiazide diuretics, estrogen replacement therapy
- Pregnant or lactating women
- Patients with other severe disease that could interfere with the results of the study.
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 |
|---|---|---|
| AB-LIFE with Monacolin KRed yeast rice extract (also known by its scientific name, Monascus purpureus) certified to contain 10 mg of monacolin K, plus 1 billion total cfu of AB-LIFE probiotic formula, which is composed of 3 Lactoplantibacillus plantarum (formerly known as Lactobacillus plantarum) strains: CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™), all in a maltodextrin carrier. Capsules are of vegetable origin (hydroxypropylmethyl cellulose). | Dietary supplement | Nutraceutical |
| PlaceboPlacebo capsules containing maltodextrin carrier only. Capsules are of vegetable origin (hydroxypropylmethyl cellulose). | Other | Control |
Primary outcome
Change in low density lipoprotein cholesterol (LDL-C)
Time frame: 0, 6 and 12 weeks
Fasting serum levels of low density lipoprotein cholesterol (LDL-C), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).
8 secondary outcomes
Change in total cholesterol (TC)
Time frame: 0, 6 and 12 weeks
Change in high density lipoprotein cholesterol (HDL-C)
Time frame: 0, 6 and 12 weeks
Change in triglycerides (TG)
Time frame: 0, 6 and 12 weeks
Change in Body Mass Index (BMI)
Time frame: 0 and 12 weeks
Change in body weight
Time frame: 0 and 12 weeks
Change in percent body fat
Time frame: 0 and 12 weeks
Patient satisfaction with treatment
Time frame: 12 weeks
Treatment-emergent adverse effects
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.
Rafael Guerrero Bonmatty, PhD principal investigator
University of Extremadura (SPAIN)
Questions about this trial
What is this clinical trial studying?
A study testing AB-LIFE with Monacolin K in people with Hypercholesterolemia, run by AB Biotics, SA.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in low density lipoprotein cholesterol (LDL-C) (time frame: 0, 6 and 12 weeks). 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 22 Jan 2021.