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

This study is not yet open for participant recruitment.
Verified February 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Pierre singer, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01565252
First received: March 9, 2012
Last updated: February 15, 2013
Last verified: February 2013
History of Changes

March 9, 2012
February 15, 2013
April 2013
May 2014   (final data collection date for primary outcome measure)
Glycemic levels [ Time Frame: before meal and 30 and 60 minutes after meal ] [ Designated as safety issue: No ]
Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test
Same as current
Complete list of historical versions of study NCT01565252 on ClinicalTrials.gov Archive Site
  • Fatty Acid Composition [ Time Frame: Study Days:1,21,43 and 63 ] [ Designated as safety issue: No ]
    ω3 incorporation into blood cell membranes(RBC)
  • C-Reactive protein [ Time Frame: Study Days:1, 21, 43 and 63 ] [ Designated as safety issue: No ]
    measures associated with CVD (Cardiovascular disease) risks
  • MDA(Malondialdehyde) [ Time Frame: Study days: 1,21,43 and 63 ] [ Designated as safety issue: No ]
    Measures associated with CVD (Cardiovascular disease) risks
Same as current
Not Provided
Not Provided
 
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

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 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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Healthy Volunteers
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.
  • 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.
    Intervention: Dietary Supplement: eggs enriched Omega-3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
August 2014
May 2014   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact: Pierre Singer, MD,Professor 972-3-9376521 psinger@clalit.org.il
Contact: Milana Grinev, Study Coordinator 972-3-9376521 milang@clalit.org.il
Israel
 
NCT01565252
6445
Yes
Pierre singer, Rabin Medical Center
Rabin Medical Center
Not Provided
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
Rabin Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP