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临床试验/NCT02259205
NCT02259205Unknown不适用

Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products

Harokopio University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Changes in Platelet aggregation

研究概览

简要总结

This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted from olive mill waste in platelet aggregation and other inflammatory and oxidative stress markers. The study will include three groups: the intervention group will receive the enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt consumption).

详细描述

Cardiovascular diseases are the leading cause of mortality worldwide. Data from the investigators research group indicate that platelet activating factor (PAF) is one of the most important inflammatory factors and the main mediator of thrombosis during the formation of atherosclerotic plaque. Thus, dietary interventions aimed at inhibition of PAF is of particular importance in public health level. The aim of the study is to examine the efficacy of administering in humans bioactive lipids extracted from olive mill waste (with proven in vitro anti-thrombotic activity and in vivo anti-atherosclerotic properties in rabbits fed an atherogenic diet) to inhibit the activity of PAF and other inflammatory mediators.

Bioactive lipids are isolated by standardized methodology of oil manufacture byproducts. Preliminary studies have been done in animals to establish the safety of administration of these compounds and to clarify the effective dosages of administration for inhibiting formation of atherosclerotic plaques. The effectiveness of these compounds in humans will be examined in a randomized, double-blind clinical trial in subjects aged 40-60 years, lasting eight weeks. Supplementation with the bioactive lipids will be in the form of an enriched yogurt provided daily. The study includes three groups: treatment group, where enriched yogurt will be provided, plain yogurt treatment group and no consumption of yogurt group . Parameters that will be assessed are the inhibition of platelet aggregation (with three different stimuli, including PAF), lipid profile, inflammatory markers such as CRP, IL-6, TNFa, and oxidative stress markers.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • All individuals, aged 40-60 years, without any of the

排除标准

  • Exclusion Criteria:
  • Any anti-inflammatory medication
  • Hyper-lipidemic medications
  • Use of antibiotics within two months from study entry
  • Pregnancy or childbirth in the previous year
  • Intake of any nutritional supplement
  • Any serious dental, respiratory, liver, kidney, gastrointestinal disease

研究组 & 干预措施

Enriched Yogurt

Experimental

150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks

干预措施: Enriched Yogurt (Other)

Plain Yogurt

Placebo Comparator

150 g not enriched yogurt provided daily for 8 weeks

干预措施: Plain Yogurt (Other)

Control

No Intervention

No yogurt consumption

结局指标

主要结局

Changes in Platelet aggregation

时间窗: 0 (baseline), end of 4th week and 8th week

The ability of platelets to aggregate will be measured in platelet rich plasma (PRP) of volunteers using PAF, thrombin and ADP as aggregating factor.

次要结局

  • Changes in Blood lipid profile(0 (baseline), end of 4th week and 8th week)
  • Changes in Inflammation-related markers(0 (baseline), end of 4th week and 8th week)
  • Change in Dietary intake(0 (baseline), end of 8th week)
  • Changes in Glucose and Insulin(0 (baseline), end of 4th week and 8th week)
  • Changes in Oxidative stress(0 (baseline), end of 4th week and 8th week)
  • Changes in Gastro-intestinal symptoms(0 (baseline), end of 4th week and 8th week)
  • Changes in Gut microbiota populations(0 (baseline), end of 8th week)

研究者

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

Smaragdi Antonopoulou

Professor in Biochemistry

Harokopio University

研究点 (2)

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