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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
University of Bologna·ClinicalTrials.gov·dietary supplementNot yet recruiting
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Study focus
Disease/Condition
Hypercholesterolemia
Drug/Device/Intervention
Red yeast rice
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
University of Bologna
Location
Bologna, Italy
Timeline & enrollment
Phase
N/A
Start date
May 02, 2024
End date
May 02, 2025
Enrollment
40 participants
Primary outcome

Treatment-dependent change in LDL-C

Summary

The primary purpose of our research will be to evaluate if, in healthy subjects with a low-
 moderate cardiovascular risk (CV risk1% 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.

ICD-10 classifications
Pure hypercholesterolaemiaLipoprotein deficiencyHyperglycaemia, unspecifiedDisorders of lipoprotein metabolism and other lipidaemiasOther disorders of lipoprotein metabolism
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06368258
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06368258 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Bologna and is currently Not yet recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.