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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eggs enriched Omega-3 | Dietary Supplement | In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Singer, MD,Professor | Contact | 972-3-9376521 | psinger@clalit.org.il | |
| Milana Grinev, Study Coordinator | Contact | 972-3-9376521 | milang@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Singer, Professor,MD | ICU dep't, Institute for Nutrition Research, Rabin MC | Principal Investigator |
| Niva Shapiro, Ph.D.,R.D. | Institute for Nutrition Research, Rabin MC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Campus Beilinson | Petah Tikva | Petach Tikva | 49100 | Israel |
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| Study Days:1, 21, 43 and 63 |
| MDA(Malondialdehyde) | Measures associated with CVD (Cardiovascular disease) risks | Study days: 1,21,43 and 63 |
| Milana Grinev, Study Coordinator | ICU dep't, Institute for Nutrition Research, Rabin MC | Study Director |