Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects

Not Applicable

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: eggs enriched Omega-3

• Registration Number: NCT01565252
• Lead Sponsor: Rabin Medical Center

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.

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.

Study Timeline

• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Status Verified: 2013-02
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25
• Study Start: 2014-04
• Primary Completion: 2015-05
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Healthy men volunteers (age 18-45 years)
2. BMI 23-28

Exclusion Criteria

1. Use of lipid-modifying medications or nutritional supplements
2. Known malignancy
3. Allergy to eggs or other materials use in the experiment
4. Substance abuse (including alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stage 2	eggs enriched Omega-3	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.

Primary Outcome Measures

Name	Time	Method
Glycemic levels	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 Outcome Measures

Name	Time	Method
Fatty Acid Composition	Study Days:1,21,43 and 63	ω3 incorporation into blood cell membranes(RBC)
C-Reactive protein	Study Days:1, 21, 43 and 63	measures associated with CVD (Cardiovascular disease) risks
MDA(Malondialdehyde)	Study days: 1,21,43 and 63	Measures associated with CVD (Cardiovascular disease) risks

Trial Locations

Locations (1)

Rabin Medical Center, Campus Beilinson; 🇮🇱 Petach Tikva, Israel