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

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ClinicalTrials.gov Identifier: NCT01565252
Recruitment Status : Unknown
Verified February 2013 by Pierre singer, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 28, 2012
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Pierre singer, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 28, 2012
Last Update Posted Date November 25, 2013
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Glycemic levels [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • Fatty Acid Composition [ Time Frame: Study Days:1,21,43 and 63 ]
    ω3 incorporation into blood cell membranes(RBC)
  • C-Reactive protein [ Time Frame: Study Days:1, 21, 43 and 63 ]
    measures associated with CVD (Cardiovascular disease) risks
  • MDA(Malondialdehyde) [ Time Frame: Study days: 1,21,43 and 63 ]
    Measures associated with CVD (Cardiovascular disease) risks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 27, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565252
Other Study ID Numbers  ICMJE 6445
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierre singer, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Rabin Medical Center
Verification Date February 2013

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