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临床试验/NCT03988153
NCT03988153已完成1 期

Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function in Mild Hypercholesterolemic Volunteers: A Placebo-control, Randomized Clinical Trial

Chung Shan Medical University0 个研究点目标入组 40 人开始时间: 2010年11月10日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
主要终点
Fecal Characteristics

研究概览

简要总结

Probiotic contained milk formula (PMF) intervention for 10 weeks considerably improves gastrointestinal function by modulating fecal movement, intestinal microflora as well as decrease cholesterol and thus help in the management of hypercholesterolemia.

详细描述

Current randomized placebo-controlled, double-blind was designed to assess the effect of probiotic contained milk formula (PMF) on lipid profile and intestinal function in healthy mild hypercholesterolemic subjects. Totally forty healthy mild hypercholesterolemic subjects (180-220 mg/dL) were randomly chosen and divided into two groups as placebo or experimental group. All the subjects were requested to drink either PMF (experimental) or skimmed milk drink formula-Placebo (30 gm mixed with 200 mL of water) for 10 weeks and continued by 2 weeks of the follow-up period. Supplementation of PMF for 10 weeks significantly improved (p< 0.05) the fecal weight, fecal movement (decreased fecal GI passing time) by improving intestinal microflora (increasing beneficial bacterial species like Lactobacillus, Bifidobacterium spp) and Lag time of LDL oxidation. In addition, intake of PMF substantially reduced (p< 0.05) the levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c) and thus showcasing its cardioprotective efficacy. Therefore PMF is recommended for the management of hypercholesterolemia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy mild hypercholesterolemic subjects (180-220 mg/dL)

排除标准

  • Subjects who took antibiotics or supplements (vitamins or minerals), probiotics (especially dairy products), Subjects suffering from severe gastrointestinal, cardiovascular, hepatic or renal disorders, Lactating or pregnant women, chain smokers.

结局指标

主要结局

Fecal Characteristics

时间窗: 12 weeks

Intervention with PMF to check the change in fecal weight (mg)

Intestinal microflora

时间窗: 12 weeks

Intervention with PMF to check the change in fecal Lactobacillus spp content (1 mg)

次要结局

  • Lipid profile(12 weeks)
  • Lag time of LDL oxidation(12 weeks (5 min incubation))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chin Kun Wang

Professor

Chung Shan Medical University

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