临床试验/NCT01565252

NCT01565252Unknown不适用

Assessment of the Effect of n-3(Omega 3) Fortified Egg Compared to Omega-6 Israeli Regular Egg on Metabolic, Inflammation and Other Physiologic Parameters Prospective, Crossover, Compared Study in Healthy Subjects

Rabin Medical Center2 个研究点分布在 1 个国家目标入组 20 人开始时间: 2014年4月最近更新: 2013年11月25日

适应症

试验速览

阶段: 不适用
发起方: Rabin Medical Center
入组人数: 20
试验地点: 2
主要终点: Glycemic levels

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study Rationale:

As epidemiological research has shown negative effects of high egg consumption on increased all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate their effects on diseases risks, it is important to test the effect of eggs with different composition on markers associated with dyslipidemia, dysglycemia and inflammation.

The aim of this study is to assess the effect of n-3PUFA (Omega 3) fortified egg compared to omega-6 Israeli regular egg on metabolic, inflammation and other physiologic parameters.

详细描述

STUDY OBJECTIVES

First endpoint:

To assess the effect of high n-3 PUFA (Omega 3) egg, as compared to regular- high n-6 PUFA (Omega 6) Israeli egg, on glycemic levels after night fasting and post prandial of 2 egg breakfast test meal.

Secondary endpoint:

To compare the effect of high n-3 PUFA fortified egg versus high n-6 PUFA (Regular) egg on measures associated with CVD risks including: CRP, LDL oxidation, MDA, post prandial Flow mediated dilatation (FMD), liver enzymes, and blood lipids and lipoproteins, and further blood chemistry measures.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Crossover
主要目的: Supportive Care
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy men volunteers (age 18-45 years)

排除标准

•Use of lipid-modifying medications or nutritional supplements
•Known malignancy
•Allergy to eggs or other materials use in the experiment
•Substance abuse (including alcohol

结局指标

主要结局

Glycemic levels

时间窗: before meal and 30 and 60 minutes after meal

Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test

次要结局

Fatty Acid Composition(Study Days:1,21,43 and 63)
C-Reactive protein(Study Days:1, 21, 43 and 63)
MDA(Malondialdehyde)(Study days: 1,21,43 and 63)

研究者

发起方

Rabin Medical Center

申办方类型

Other

责任方

Principal Investigator

主要研究者

Pierre singer

Professor, MD

Rabin Medical Center

研究点 (2)

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