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

Hypercholesterolemia Clinical Trial

Official title:

Randomized Clinical Trial to Evaluate the Middle Term Effect of a Dietary Supplement Containing Red Yeast Rice (Total Monacolin <3 mg/Dose) or Placebo on Plasma Lipids and Proteoma in Subjects With Suboptimal Cholesterolemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368258
• Other study ID #: Curr-RYR2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: May 2, 2025

Study information

• Verified date: April 2024
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Red yeast rice
Red yeast rice 160 mg (total monacolins 2.8 mg)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	AOU Policlinico S.Orsola-Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Treatment-dependent change in Non-HDL-C	To compare the effect of the tested dietary supplement on Non-HDL cholesterol level after 6 weeks of treatment vs placebo vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Secondary	Treatment-dependent change in liver parameters	To evaluate if the tested dietary supplement is associated with changes in liver parameters (i.e. AST, ALT, gamma-GT) vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Secondary	Treatment-dependent change in CPK plasma levels	To evaluate if the tested dietary supplement is associated with changes in CPK plasma levels compared to placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Secondary	Treatment-dependent change in plasma proteomic pattern	To evaluate if the tested dietary supplement is associated with significant changes on plasma proteomic pattern with focus on liver and muscle protein parameters in healthy subjects with suboptimal cholesterolemia. Protein abundances will be calculated with the generation of spectral features by the node FeatureFinderMultiplex followed by PIA-assisted FDR-multiple scores estimation and filtering (combined FDR score<0.01), their ID mapping and combination with peptide IDs, their subsequent alignment, grouping and normalization (e.g., MapAlignerIdentification, FeatureUnlabeledQT and ConsensusmapNormalizer nodes).	6 weeks