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一项随机、双盲、安慰剂对照试验，研究黄酵母米对轻度至中度高胆固醇血症成年人的降胆固醇作用及安全性：研究方案。

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.

作者信息

Jeong Sewon, Lee Jaekyung, Kwon Oran, Kim Ji Won, Oh Bumjo

机构信息

BiofoodCRO Co, Ltd, Seodaemun-gu Department of Internal Medicine, SMG-SNU Boramae Medical Centre, Dongjak-gu Department of Nutritional Science and Food Management, Ewha Womans University Biofood Network, Seodaemun-gu Department of Family Medicine, SMG-SNU Boramae Medical Center, Dongjak-gu, Seoul, Korea.

出版信息

Medicine (Baltimore). 2018 Jul;97(30):e11634. doi: 10.1097/MD.0000000000011634.

DOI:10.1097/MD.0000000000011634
PMID:30045307
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6078669/
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:Participants 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.

摘要

背景

血脂升高是心血管疾病的公认危险因素。为降低心血管疾病风险，降低血液胆固醇水平的预防策略至关重要，这些策略包括生活方式改变和降胆固醇药物。我们旨在通过一项随机、对照、双盲和平行组研究，调查黄曲霉素米的降胆固醇效果和安全性。

方法

本研究的参与者将根据以下纳入标准进行选择：参与者被随机分配到安慰剂组或黄曲霉素米治疗组。低密度脂蛋白胆固醇（LDL-C）水平轻度至中度升高的参与者将每天两次食用1袋黄曲霉素米粉（含莫纳可林K）或安慰剂，持续8周。接下来，将评估血脂情况。

结果

本研究所需的参与者数量为68名，目前正在招募参与者。参与者被随机分配到对照组和干预组。

结论

这是第一项针对轻度至中度高胆固醇血症成年人，研究黄曲霉素米的降胆固醇效果和安全性的人体干预研究。此外，这是一项考虑了饮食习惯、生活方式因素和遗传因素等混杂因素的随机、双盲、安慰剂对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/330f/6078669/f9b814b57700/medi-97-e11634-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/330f/6078669/e4e67592aed1/medi-97-e11634-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/330f/6078669/f9b814b57700/medi-97-e11634-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/330f/6078669/e4e67592aed1/medi-97-e11634-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/330f/6078669/f9b814b57700/medi-97-e11634-g003.jpg

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