Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects (PisNShMiGSL-01)
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||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|
- Glycemic levels [ Time Frame: before meal and 30 and 60 minutes after meal ] [ Designated as safety issue: No ]Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test
- Fatty Acid Composition [ Time Frame: Study Days:1,21,43 and 63 ] [ Designated as safety issue: No ]ω3 incorporation into blood cell membranes(RBC)
- C-Reactive protein [ Time Frame: Study Days:1, 21, 43 and 63 ] [ Designated as safety issue: No ]measures associated with CVD (Cardiovascular disease) risks
- MDA(Malondialdehyde) [ Time Frame: Study days: 1,21,43 and 63 ] [ Designated as safety issue: No ]Measures associated with CVD (Cardiovascular disease) risks
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
No Intervention: Stage 1
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
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
In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.
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.
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.
To assess the influence of n-3 Egg on erythrocytes fatty acid profile.
Study design: Prospective, Crossover, Compared Study Study population: 20 Healthy subjects
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565252
|Contact: Pierre Singer, MD,Professoremail@example.com|
|Contact: Milana Grinev, Study Coordinatorfirstname.lastname@example.org|
|Rabin Medical Center, Campus Beilinson||Not yet recruiting|
|Petach Tikva, Israel, 49100|
|Contact: Pierre Singer, Professor ,MD 972-39376521 email@example.com|
|Contact: Milana Grinev, Study Coordinator 972-39376521 firstname.lastname@example.org|
|Principal Investigator:||Pierre Singer, Professor,MD||ICU dep't, Institute for Nutrition Research, Rabin MC|
|Study Chair:||Niva Shapiro, Ph.D.,R.D.||Institute for Nutrition Research, Rabin MC|
|Study Director:||Milana Grinev, Study Coordinator||ICU dep't, Institute for Nutrition Research, Rabin MC|