Clinical trial NCT01565252: Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: Egg,Omega 3, Omega 6
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic levels
timeFrame: before meal and 30 and 60 minutes after meal
Secondary outcomes:
measure: Fatty Acid Composition
timeFrame: Study Days:1,21,43 and 63
measure: C-Reactive protein
timeFrame: Study Days:1, 21, 43 and 63
measure: MDA(Malondialdehyde)
timeFrame: Study days: 1,21,43 and 63
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Campus Beilinson
Study officials:
affiliation: ICU dep't, Institute for Nutrition Research, Rabin MC
name: Pierre Singer, Professor,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Nutrition Research, Rabin MC
name: Niva Shapiro, Ph.D.,R.D.
role: STUDY_CHAIR
affiliation: ICU dep't, Institute for Nutrition Research, Rabin MC
name: Milana Grinev, Study Coordinator
role: STUDY_DIRECTOR
References: