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临床试验/NCT04029818
NCT04029818已完成1 期

Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers

Biosearch S.A.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月24日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
LDL-cholesterol

研究概览

简要总结

The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals.

详细描述

There is a strong correlation between LDL-cholesterol and cardiovascular diseases.

Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.

Several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Levels of LDL-cholesterol between 100 and 190 mg/dL.
  • Accept freely to participate in the study and sign the informed consent document.

排除标准

  • Be pregnant.
  • Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
  • Having a serious illness.
  • Having diabetes.
  • Having a cerebrovascular disease.
  • Being allergic to any group of antibiotics.
  • Take probiotics in the form of supplements at least 4 weeks before.
  • Take antibiotics at least 4 weeks before.
  • Being taking products or drugs to control cholesterol levels

结局指标

主要结局

LDL-cholesterol

时间窗: 8 weeks

Levels of LDL-cholesterol in plasma

次要结局

  • HDL-cholesterol(8 weeks)
  • Total cholesterol(8 weeks)
  • Glucose(8 weeks)
  • Body mass index(8 weeks)
  • Triglycerides(8 weeks)
  • Blood pressure(8 weeks)

研究者

发起方
Biosearch S.A.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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