NCT02492464

Brief Summary

This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)

Trial Health

87
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 May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

June 22, 2015

Last Update Submit

January 30, 2024

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilation (FMD) change from the baseline to the end of treatment period

    6 months

Secondary Outcomes (1)

  • 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period

    6 months

Study Arms (2)

Red yeast rice

ACTIVE COMPARATOR

Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months

Dietary Supplement: Red yeast rice

Placebo

PLACEBO COMPARATOR

Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months

Dietary Supplement: Placebo

Interventions

Red yeast riceDIETARY_SUPPLEMENT

1 capsule to be taken before to sleep, each day, for 6 months

Red yeast rice
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

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

You may qualify if:

  • LDL-cholesterol between 130 and 190 mg/dL

You may not qualify if:

  • Secundary prevention for cardiovascular disease
  • Type 2 diabetes
  • Assumption of lipid-lowering drug or dietary supplements
  • Previous intolerans to read yeast rice including dietary supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

Location

Related Publications (2)

  • Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. Ann Nutr Metab. 2016;68(3):213-9. doi: 10.1159/000445359. Epub 2016 Apr 8.

    PMID: 27055107RESULT

  • Cicero AFG, Fogacci F, Bove M, Veronesi M, Rizzo M, Giovannini M, Borghi C. Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. Adv Ther. 2017 Aug;34(8):1966-1975. doi: 10.1007/s12325-017-0580-1. Epub 2017 Jul 7.

    PMID: 28687937DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

red yeast rice

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Claudio Borghi

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 8, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)