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Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia - Trial NCT06368258

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.

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NCT06368258
Not yet recruiting
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT06368258
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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

Study Focus

Hypercholesterolemia

Red yeast rice

Interventional

dietary supplement

Sponsor & Location

University of Bologna

Bologna, Italy

Timeline & Enrollment

N/A

May 02, 2024

May 02, 2025

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 hypercholesterolaemia
Lipoprotein deficiency
Hyperglycaemia, unspecified
Disorders of lipoprotein metabolism and other lipidaemias
Other disorders of lipoprotein metabolism

Data Source

ClinicalTrials.gov

NCT06368258

Non-Device Trial