Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects
PisNShMiGSL-01
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Apr 2014
Typical duration for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 25, 2013
February 1, 2013
1.1 years
March 9, 2012
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic levels
Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test
before meal and 30 and 60 minutes after meal
Secondary Outcomes (3)
Fatty Acid Composition
Study Days:1,21,43 and 63
C-Reactive protein
Study Days:1, 21, 43 and 63
MDA(Malondialdehyde)
Study days: 1,21,43 and 63
Study Arms (2)
Stage 1
NO INTERVENTIONDietary 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
EXPERIMENTALStage 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.
Interventions
In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.
Eligibility Criteria
You may qualify if:
- Healthy men volunteers (age 18-45 years)
- BMI 23-28
You may not qualify if:
- Use of lipid-modifying medications or nutritional supplements
- Known malignancy
- Allergy to eggs or other materials use in the experiment
- Substance abuse (including alcohol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical Center, Campus Beilinson
Petah Tikva, Petach Tikva, 49100, Israel
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
March 9, 2012
First Posted
March 28, 2012
Study Start
April 1, 2014
Primary Completion
May 1, 2015
Study Completion
August 1, 2015
Last Updated
November 25, 2013
Record last verified: 2013-02