Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: eggs enriched Omega-3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Stage 1<br>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. | |
| Experimental: Stage 2<br>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. | Dietary Supplement: eggs enriched Omega-3<br>* In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic levels | Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test | before meal and 30 and 60 minutes after meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatty Acid Composition | ω3 incorporation into blood cell membranes(RBC) | Study Days:1,21,43 and 63 | 
| C-Reactive protein | measures associated with CVD (Cardiovascular disease) risks | Study Days:1, 21, 43 and 63 | 
| MDA(Malondialdehyde) | Measures associated with CVD (Cardiovascular disease) risks | Study days: 1,21,43 and 63 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Egg,Omega 3, Omega 6