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
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Glycemic levels
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
研究组 & 干预措施
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.
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.
干预措施: eggs enriched Omega-3 (Dietary Supplement)
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
Pierre singer
Professor, MD
Rabin Medical Center