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临床试验/NCT03540108
NCT03540108已完成不适用

The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum ECGC 13110402 (LPLDL®) in Hypercholesterolemic Adults

University of Roehampton2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Effect on the gut microbiota

研究概览

简要总结

Coronary heart disease (CHD) is one of the major causes of death and disability in industrialised countries. Results from several epidemiological and clinical studies indicate a positive correlation between elevated total serum cholesterol levels, mainly reflecting the LDL-cholesterol fraction, and risk of CHD. It is thought that a reduction in total plasma cholesterol levels in populations suffering from primary hypercholesterolemia (elevated cholesterol) can lower the incidence of coronary thrombosis. Currently, therefore there is extensive interest in the management of serum cholesterol and other blood lipids. Diet is viewed as a major influencing factor that can reduce levels. This is largely driven by the expense of drug therapy, the large numbers of individuals affected and unwanted side effects of such treatments. Dietary strategies for prevention of CHD implicate adherence to a low-fat/low-saturated fat diet. Although such diets may present an effective approach, they are difficult to maintain on a long-term basis and efficacy diminishes over time. As such, new approaches towards identification of other dietary means of reducing blood cholesterol levels have been evaluated. These include, among others, the use of probiotics. Probiotics are 'live microbial feed supplements that offer a benefit to health'. They are marketed as health or functional foods whereby they are ingested for their purported positive advantages in the digestive tract and/or systemic areas like the liver, vagina or bloodstream. The main goal of the study is to test the efficacy of the probiotic in degrading cholesterol as well as produce metabolites that interfere with its synthesis in the liver in adults with high cholesterol (>6mmol). The effect may also be partially ascribed to an enzymatic deconjugation of bile acids.

详细描述

The aim of this human volunteer study is to establish the extent of extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 50 hypercholesterolaemic adults (35-70 years old).

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

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • males and females from 35 to 70 years of age
  • BMI 18.5 to 29.9 kg/m2
  • total cholesterol (TC) >6mmol/L.

排除标准

  • suffering from chronic gastrointestinal complaints (including chronic constipation, diarrhoea or Irritable Bowel Syndrome)
  • diabetes or anaemia
  • requirement to take long-term medications active on the gastrointestinal tract, treatment of cardio-vascular disease, or any other long-term medication
  • high blood cholesterol or use of cholesterol lowering drugs/ functional foods
  • history of drug or alcohol misuse or alcohol consumption exceeding 14 and 21 units/week for females and males respectively
  • those suffering with any allergies to medication or food
  • on weight-reducing diets.
  • Females planning pregnancy within six months from the start of the study, lactating, or have given birth within the preceding six months
  • use of antibiotics within six months preceding the study, participation in any probiotic, prebiotic or laxative study or intake of an experimental drug four weeks prior to the study start.
  • Individuals exercising > 16 744 kJ per week

结局指标

主要结局

Effect on the gut microbiota

时间窗: from baseline to 6 and 12 weeks of the intervention

To determine the effect of LPLDL® on the faecal microbiota composition and microbial activity of the volunteers using DNA profiling from faeces (16s rRNA sequencing using Illumina MiSeq Platform and QIIME data analysis software).

Effect on vitamin D absorption and ABOB

时间窗: from baseline to 6 and 12 weeks of the intervention

To investigate the effect of LPLDL® on vitamin D absorption in the study population by measuring circulating vitamin D in blood using clinical chemistry and monitoring vitamin D intake from food diary.

Effect on bile acid metabolism

时间窗: from baseline to 6 and 12 weeks of the intervention

To assess any changes in bile acid metabolites and TMAO during the study trial using high performance liquid chromatography tandem mass spectrometry to analyse the urine samples.

Cholesterol-lowering efficacy

时间窗: from baseline to 6 and 12 weeks of the intervention

To test, in humans, whether the LPLDL® intervention lowers total cholesterol by a log change of min. 0.45 ± 0.4.

次要结局

  • Digestive symptoms(from baseline to 6 and 12 weeks of the intervention)
  • Dietary assessment(from baseline to 6 and 12 weeks of the intervention)

研究者

发起方
University of Roehampton
申办方类型
Other
责任方
Principal Investigator
主要研究者

DR ADELE COSTABILE

Reader in Nutrition

University of Roehampton

研究点 (2)

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