Healthy Volunteers Clinical Trial
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 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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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