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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Glycemic levels
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy men volunteers (age 18-45 years)
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
Arms & Interventions
Stage 1
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
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.
Intervention: eggs enriched Omega-3 (Dietary Supplement)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Fatty Acid Composition(Study Days:1,21,43 and 63)
- C-Reactive protein(Study Days:1, 21, 43 and 63)
- MDA(Malondialdehyde)(Study days: 1,21,43 and 63)
Investigators
Pierre singer
Professor, MD
Rabin Medical Center