scholarly journals Resveratrol improves the lipid profile promoted by red yeast rice (monacolin k) in patients with moderate dyslipidemia: An open-label, randomized, parallel-group controlled clinical trial

2017 ◽  
Vol 1 (1) ◽  
pp. 72-75
Author(s):  
Annalisa Panico ◽  
Gelsy Arianna Lupoli ◽  
Roberta Lupoli ◽  
Fiammetta Romano ◽  
Livia Barba ◽  
...  

Abstract Introduction: A relevant role is now emerging for nutraceuticals and specific functional foods in the treatment of dyslipidemia. The aim of this study was to evaluate the efficacy of a nutraceutical multi-target approach in subjects with moderate cardiovascular risk and to compare it with red yeast rice (RYR) treatment alone. Materials and Methods: Sixty patients with a first diagnosis of moderate dyslipidemia were included in a 6-week open-label, randomized, parallel-group controlled clinical trial and were treated with a nutraceutical supplement of Red Yeast Rice (RYR) extract containing 10 mg of monacolin k or its combination with 48 mg of an improved form of highly bioavailable resveratrol. The dosage of RYR was selected on the basis of its expected efficacy in reducing low-density lipoprotein- cholesterol also approved by the EFSA panel. All differences were assessed by Student’s t test with P values .05 are considered as statistically significant. Statistical analysis was performed by using Excel. Results: Treatment with RYR (10 mg monacolin K) led to a reduction of total cholesterol (20%) and low-density lipoprotein- cholesterol (21%). The combination with resveratrol however, compared to RYR alone significantly reduced triglyceride (-18 %) levels, systolic blood pressure (-2 %) and HOMA index (-17 %). Discussion: These results indicate that the nutraceutical supplementation of RYR associated with resveratrol not only shows lipid-lowering activity but compared to RYR treatment alone significantly also ameliorates other metabolic parameters. Thus, may represent a valid and safe approach, especially in people with moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate.

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023636 ◽  
Author(s):  
Akihiro Nomura ◽  
Hayato Tada ◽  
Hirofumi Okada ◽  
Atsushi Nohara ◽  
Hideki Ishikawa ◽  
...  

IntroductionFamilial hypercholesterolemia (FH) is an autosomal-dominant inherited genetic disease. High-throughput sequencing quickly and comprehensively detects causative variants of FH-related genes (LDLR,PCSK9,APOBandLDLRAP1). Although the presence of causative variants in FH-related genes correlates with future cardiovascular events, it remains unclear whether detection of causative gene mutation and disclosure of its associated cardiovascular risk affects outcomes in patients with FH. Therefore, this study intends to evaluate the efficacy of counselling future cardiovascular risk based on genetic testing in addition to standard patients’ education programme in patients with FH.Methods and analysisA randomised, waiting-list controlled, open-label, single-centre trial will be conducted. We will recruit patients with clinically diagnosed FH without previous history of coronary heart disease from March 2018 to December 2019, and we plan to follow up participants until March 2021. For the intervention group, we will perform genetic counselling and will inform an estimated future cardiovascular risk based on individuals’ genetic testing results. The primary endpoint of this study is the plasma low-density lipoprotein cholesterol level at 24 weeks after randomisation. The secondary endpoints assessed at 24 and 48 weeks are as follows: blood test results; smoking status; changes of lipid-lowering agents’ regimen and Patients Satisfaction Questionnaire Short Form scores among the four groups divided by the presence of genetic counselling and genetic status of FH.Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects and all other applicable laws and guidelines in Japan. This study protocol was approved by the IRB at Kanazawa University. We will disseminate the final results at international conferences and in a peer-reviewed journal.Trial registration numberUMIN000029375.


Sign in / Sign up

Export Citation Format

Share Document