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
- 주제(키워드) biomarkers , functional food , high serum cholesterol , randomized controlled trial , treatment outcome
- 주제(기타) Medicine, General & Internal
- 설명문(일반) [Jeong, Sewon] BiofoodCRO Co Ltd, Seoul, South Korea; [Lee, Jaekyung; Kim, Ji Won] SMG SNU Boramae Med Ctr, Dept Internal Med, Seoul, South Korea; [Kwon, Oran] Ewha Womans Univ, Dept Nutr Sci & Food Management, Seoul, South Korea; [Kwon, Oran] Biofood Network, Seoul, South Korea; [Oh, Bumjo] SMG SNU Boramae Med Ctr, Dept Family Med, 20 Boramae Ro 5 Gil, Seoul 07061, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 LIPPINCOTT WILLIAMS & WILKINS
- 발행년도 2018
- URI http://www.dcollection.net/handler/ewha/000000156328
- 본문언어 영어
- Published As http://dx.doi.org/10.1097/MD.0000000000011634
초록/요약
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.
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