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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, Sewon; Lee, Jaekyung; Kwon, Oran; Kim, Ji Won; Oh, Bumjo
- Ewha Authors
- 권오란
- SCOPUS Author ID
- 권오란
![scopus](/images/layout/icon2.png)
- Issue Date
- 2018
- Journal Title
- MEDICINE
- ISSN
- 0025-7974
1536-5964
- Citation
- MEDICINE vol. 97, no. 30
- Keywords
- biomarkers; functional food; high serum cholesterol; randomized controlled trial; treatment outcome
- Publisher
- LIPPINCOTT WILLIAMS &
WILKINS
- Indexed
- SCIE; SCOPUS
![scopus](/images/layout/scopus2.gif)
- Document Type
- Article
- 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
- Appears in Collections:
- 신산업융합대학 > 식품영양학과 > Journal papers
- Files in This Item:
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