Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects (PisNShMiGSL-01)
|ClinicalTrials.gov Identifier: NCT01565252|
Recruitment Status : Unknown
Verified February 2013 by Pierre singer, Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : March 28, 2012
Last Update Posted : November 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Dietary Supplement: eggs enriched Omega-3||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, 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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||August 2015|
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.
- Glycemic levels [ Time Frame: 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
- Fatty Acid Composition [ Time Frame: Study Days:1,21,43 and 63 ]ω3 incorporation into blood cell membranes(RBC)
- C-Reactive protein [ Time Frame: Study Days:1, 21, 43 and 63 ]measures associated with CVD (Cardiovascular disease) risks
- MDA(Malondialdehyde) [ Time Frame: Study days: 1,21,43 and 63 ]Measures associated with CVD (Cardiovascular disease) risks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565252
|Contact: Pierre Singer, MD,Professorfirstname.lastname@example.org|
|Contact: Milana Grinev, Study Coordinatoremail@example.com|
|Rabin Medical Center, Campus Beilinson||Not yet recruiting|
|Petach Tikva, Israel, 49100|
|Contact: Pierre Singer, Professor ,MD 972-39376521 firstname.lastname@example.org|
|Contact: Milana Grinev, Study Coordinator 972-39376521 email@example.com|
|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|