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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
  Purpose

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.


Condition Intervention
Healthy Volunteers
 Dietary Supplement: eggs enriched Omega-3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565252

Contacts
Contact: Pierre Singer, MD,Professor 972-3-9376521 psinger@clalit.org.il
Contact: Milana Grinev, Study Coordinator 972-3-9376521 milang@clalit.org.il

Locations
Israel
Rabin Medical Center, Campus Beilinson Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Pierre Singer, Professor ,MD     972-39376521     psinger@clalit.org.il    
Contact: Milana Grinev, Study Coordinator     972-39376521     milang@clalit.org.il    
Sponsors and Collaborators
Rabin Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Pierre singer, Professor, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01565252     History of Changes
Other Study ID Numbers: 6445
Study First Received: March 9, 2012
Last Updated: February 15, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Egg,Omega 3, Omega 6

ClinicalTrials.gov processed this record on May 16, 2013