Middle Term Effect of Red Yeast Rice on Plasma Lipids and... | NCT06368258

Studies
Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia

NCT06368258

Sponsor

University of Bologna

Status

Unknown status

Last Update Posted

Apr 16, 2024Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Hypercholesterolemia

Interventions

Red yeast rice
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2024Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

May 2, 2025Estimated

First Submitted Date

Apr 7, 2024

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
Dietary supplement	Active Comparator		Dietary Supplement: Red yeast rice
Placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Red yeast rice	Dietary Supplement	Red yeast rice 160 mg (total monacolins 2.8 mg)	Dietary supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment-dependent change in LDL-C	The primary objective is to evaluate the effect of the tested dietary supplement containing less than 3 mg of total monacolins per daily dose on LDL cholesterol level versus placebo after 6 weeks of treatment vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Treatment-dependent change in Total Cholesterol	To compare the effect of the tested dietary supplement on total cholesterol level after 6 weeks of treatment vs placebo vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Treatment-dependent change in Non-HDL-C

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged ≥ 30 years and ≤ 70 years old.
Body Mass Index included between 18 Kg/m2 and 35 Kg/m2
Total cholesterolemia between 200 and 280 mg/dL and/or LDL-Cholesterol between 130 mg/dL and 190 mg/dL.
TG<400 mg/dL.
Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
Subjects agree to participate in the study and having dated and signed the informed consent form.

Exclusion Criteria:

Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism;
Assumption of any kind of drug treatment non-stabilized for at least 3 months;
Known current thyroid, gastrointestinal or hepatobiliary diseases (including liver transaminases ≥3ULN), as well as any muscular disorders (even subclinical, including serum CPK ≥3ULN);
Current or previous alcohol abuse;
Pregnancy and Breastfeeding
Known previous intolerance to red yeast rice
History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
Any medical or surgical condition that would limit the patient adhesion to the study protocol.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases