The Effect of the Consumption of Low-Fat Milk Enriched With Plant Sterols on Serum Low-Density Lipoprotein Cholesterol in Healthy Southern Chinese (COME-PASS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 主要终点
- Mean of serum low-density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Half of the participants will consume of 1.5g of plant sterols daily as provided by two servings of the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half will consume placebo low-fat milk.
详细描述
Plant sterols are the naturally occurring functional equivalent of mammalian cholesterol. Plant sterols differ structurally from cholesterol by a methyl or ethyl group in their side chains and are not synthesized by the human body. These structural differences render them minimally absorbable in the intestine. It has been consistently reported that dietary incorporation of plant sterols(1.5-2 g/day) reduces serum low-density lipoprotein cholesterol (LDL-C) levels with minimal adverse events. The hypochoelsterolemic effects of plant sterols is explained by an inhibition of cholesterol absorption, which is ascribed to a competition with intestinal cholesterol for incorporation into mixed micelles, although other possible mechanistic explanation have been proposed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Southern Chinese male or female ≥ 18years.
- •In good general health as evidenced by medical history
- •Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and discloser of research-related health information, and comply with the study data collection procedures. Provide signed and dated informed consent form
排除标准
- •Subject with familial hypercholesterolemia
- •Ingestion of drugs known to interfere with lipid profiles, such as hormone replacement treatment, diuretics, beta-blockers, statin or other hypochoelsterolemic drug treatment
- •Smoking > 10 cigarettes/day
- •Subject with heavy alcohol intake (Alcohol > 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day)
- •Having milk intolerance or dislike
- •Having major diseases such as diabetes (type I and type II), renal or liver diseases
- •Subject presenting known allergy or hypersensitivity to milk proteins, soy and peanut
- •Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product)
- •Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- •Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
- •Pregnancy or lactation
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
结局指标
主要结局
Mean of serum low-density lipoprotein cholesterol (LDL-C)
时间窗: From baseline to week 3
次要结局
- Change of total cholesterol(From baseline to week 3)
- Change of triglycerides (TAG)(From baseline to week 3)
- Change of serum LDL-C(From baseline to week 3)
- Change of high-density lipoprotein cholesterol (HDL-C)(From baseline to week 3)
- Change of serum creatinine(From baseline to week 3)
- Changes of fasting blood glucose(From baseline to week 3)
研究者
Professor Bernard Cheung
Sun Chieh Yeh Heart Foundation Professor in Cardiovascular Therapeutics
The University of Hong Kong