Clinical trial NCT06368258: Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Red yeast rice
Monacolins
Dietary supplement
Randomized clinical study
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Treatment-dependent change in LDL-C
timeFrame: 6 weeks
Secondary outcomes:
measure: Treatment-dependent change in Total Cholesterol
timeFrame: 6 weeks
measure: Treatment-dependent change in Non-HDL-C
timeFrame: 6 weeks
measure: Treatment-dependent change in liver parameters
timeFrame: 6 weeks
measure: Treatment-dependent change in CPK plasma levels
timeFrame: 6 weeks
measure: Treatment-dependent change in plasma proteomic pattern
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: AOU Policlinico S.Orsola-Malpighi
Study officials:
References: