NCT06368258

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Red yeast rice	Red yeast rice 160 mg (total monacolins 2.8 mg)
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-05-02
• Primary completion: 2024-12-01
• Completion: 2025-05-02
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: Italy