NCT04677335

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

November 27, 2020

Last Update Submit

January 19, 2021

Conditions

Hypercholesterolemia

Keywords

ProbioticLactobacillusMonacolin KMonascus purpureus

Outcome Measures

Primary Outcomes (1)

  • 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).

    0, 6 and 12 weeks

Secondary Outcomes (8)

  • Change in total cholesterol (TC)

    0, 6 and 12 weeks

  • Change in high density lipoprotein cholesterol (HDL-C)

    0, 6 and 12 weeks

  • Change in triglycerides (TG)

    0, 6 and 12 weeks

  • Change in Body Mass Index (BMI)

    0 and 12 weeks

  • Change in body weight

    0 and 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Nutraceutical

EXPERIMENTAL

Nutraceutical capsules taken once daily for 12 weeks

Dietary Supplement: AB-LIFE with Monacolin K

Control

PLACEBO COMPARATOR

Placebo capsules taken once daily for 12 weeks

Other: Placebo

Interventions

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).

Nutraceutical
PlaceboOTHER

Placebo capsules containing maltodextrin carrier only. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total cholesterol (TC) ≥200 mg/dL and statin-naïve or having recently stopped statin treatment because of statin intolerance.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Rafael Guerrero Bonmatty, PhD

    University of Extremadura (SPAIN)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 21, 2020

Study Start

October 1, 2014

Primary Completion

April 15, 2016

Study Completion

September 19, 2017

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share