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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01565252

Acronym

PisNShMiGSL-01

Enrollment

Registered

2012-03-28

Start date

2014-04-30

Completion date

2015-08-31

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Egg,Omega 3, Omega 6

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.

Interventions

DIETARY_SUPPLEMENTeggs 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Israel

Contacts

Primary ContactPierre Singer, MD,Professor

psinger@clalit.org.il972-3-9376521

Backup ContactMilana Grinev, Study Coordinator

milang@clalit.org.il972-3-9376521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026