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

Clalit Health Services

Status: Unknown

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: eggs enriched Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT01565252

6445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Stage 1

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: eggs enriched Omega-3