Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects (PisNShMiGSL-01)
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
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.
研究概览
详细说明
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.
Third endpoint:
To assess the influence of n-3 Egg on erythrocytes fatty acid profile.
Study design: Prospective, Crossover, Compared Study Study population: 20 Healthy subjects
Study Methods:
Subjects will complete two study stages. In first stage study participants will get 3 weeks regimen including 2 Regular, Israeli (high n-6 Pufa) eggs/day.
In second stage after 3 weeks washout without eggs, study participants will get 3 weeks regimen with 2 high n-3Pufa eggs/day.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Petach Tikva、以色列、49100
- Rabin Medical Center, Campus Beilinson
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy men volunteers (age 18-45 years)
- BMI 23-28
Exclusion Criteria:
- Use of lipid-modifying medications or nutritional supplements
- Known malignancy
- Allergy to eggs or other materials use in the experiment
- Substance abuse (including alcohol
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Stage 1
Dietary regimens: Stage1 - all participants (N=20) in first stage will receive two regular (high n-6 PUFA) hard-boiled eggs/day at breakfast for a three weeks period for each participant. |
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实验性的：Stage 2
Stage 2 will be conduct after 3 weeks for wash-out with no eggs.
All participants(N=20) in second stage will receive two high n-3 PUFA hard-boiled eggs/day at breakfast for a three weeks period for each participant.
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In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Glycemic levels
大体时间：before meal and 30 and 60 minutes after meal
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Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test
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before meal and 30 and 60 minutes after meal
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fatty Acid Composition
大体时间：Study Days:1,21,43 and 63
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ω3 incorporation into blood cell membranes(RBC)
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Study Days:1,21,43 and 63
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C-Reactive protein
大体时间：Study Days:1, 21, 43 and 63
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measures associated with CVD (Cardiovascular disease) risks
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Study Days:1, 21, 43 and 63
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MDA(Malondialdehyde)
大体时间：Study days: 1,21,43 and 63
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Measures associated with CVD (Cardiovascular disease) risks
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Study days: 1,21,43 and 63
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合作者和调查者
调查人员
- 首席研究员：Pierre Singer, Professor,MD、ICU dep't, Institute for Nutrition Research, Rabin MC
- 学习椅：Niva Shapiro, Ph.D.,R.D.、Institute for Nutrition Research, Rabin MC
- 研究主任：Milana Grinev, Study Coordinator、ICU dep't, Institute for Nutrition Research, Rabin MC
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 6445
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