Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects (PisNShMiGSL-01)

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 Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: eggs enriched Omega-3

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Singer, MD,Professor; Phone Number: 972-3-9376521; Email: psinger@clalit.org.il
• Study Contact Backup: Name: Milana Grinev, Study Coordinator; Phone Number: 972-3-9376521; Email: milang@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center, Campus Beilinson
    • Contact: Pierre Singer, Professor,MD; Phone Number: 972-39376521; Email: psinger@clalit.org.il
    • Contact: Milana Grinev, Study Coordinator; Phone Number: 972-39376521; Email: milang@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic levels	Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test	before meal and 30 and 60 minutes after meal

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 28, 2012

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Egg,Omega 3, Omega 6
• Other Study ID Numbers: 6445