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A randomized, double-blind, placebo-controlled trial investigating cholesterol-lowering effects and safety of yellow yeast rice in adults with mild to moderate hypercholesterolemia: A study protocol

Title
A randomized, double-blind, placebo-controlled trial investigating cholesterol-lowering effects and safety of yellow yeast rice in adults with mild to moderate hypercholesterolemia: A study protocol
Authors
Jeong, SewonLee, JaekyungKwon, OranKim, Ji WonOh, Bumjo
Ewha Authors
권오란
SCOPUS Author ID
권오란scopus
Issue Date
2018
Journal Title
MEDICINE
ISSN
0025-7974JCR Link1536-5964JCR Link
Citation
vol. 97, no. 30
Keywords
biomarkersfunctional foodhigh serum cholesterolrandomized controlled trialtreatment outcome
Publisher
LIPPINCOTT WILLIAMS & WILKINS
Indexed
SCI; SCIE; SCOPUS WOS
Abstract
Background:Elevated levels of blood lipids are well-documented risk factors for cardiovascular disease. For cardiovascular risk reduction, preventive strategies to lower blood cholesterol levels are essential, and these strategies include lifestyle modification and cholesterol-lowering agents. We aim to investigate the cholesterol-lowering effects and safety of yellow yeast rice in a randomized, controlled, double-blind, and parallel group study.Methods:Participants for this study will be selected based on the following inclusion criteria:Voluntary agreement to participate and sign the written informed consent formsMen and women (aged 20-45 years, premenopause)Body mass index: 18 to 30kg/m(2)Fasting low-density lipoprotein cholesterol (LDL-C) levels: 130mg/dLFasting triglyceride levels: <300mg/dLParticipants are randomly allocated to the placebo or yellow-yeast-rice-treated group. Participants with mild to moderately elevated LDL-C levels will consume 1 pouch of yellow yeast rice powder (containing monacolin K) or placebo twice daily for 8 weeks. Next, the lipid profiles will be evaluated.Results:The number of participants required for this study is 68, and is currently recruiting participants. Participants are randomly assigned to control group and intervention group.Conclusion:This is the first human intervention study to investigate the cholesterol-lowering effects and safety of yellow yeast rice in adults with mild to moderate hypercholesterolemia. Also, this is a randomized, double-blind, placebo-controlled trial that considers confounders, such as dietary habits, lifestyle factors, and genetic factors.
DOI
10.1097/MD.0000000000011634
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신산업융합대학 > 식품영양학과 > Journal papers
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