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

Healthy Volunteers Clinical Trial

— PisNShMiGSL-01  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01565252
• Other study ID #: 6445
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2012
• Last updated: November 21, 2013
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2013
• Source: Rabin Medical Center
• Contact: Pierre Singer, MD,Professor
• Phone: 972-3-9376521
• Email: psinger[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Campus Beilinson	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Fatty Acid Composition	?3 incorporation into blood cell membranes(RBC)	Study Days:1,21,43 and 63	No
Secondary	C-Reactive protein	measures associated with CVD (Cardiovascular disease) risks	Study Days:1, 21, 43 and 63	No
Secondary	MDA(Malondialdehyde)	Measures associated with CVD (Cardiovascular disease) risks	Study days: 1,21,43 and 63	No