Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects (PisNShMiGSL-01)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Petach Tikva, 이스라엘, 49100
- Rabin Medical Center, Campus Beilinson
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy men volunteers (age 18-45 years)
- BMI 23-28
Exclusion Criteria:
- Use of lipid-modifying medications or nutritional supplements
- Known malignancy
- Allergy to eggs or other materials use in the experiment
- Substance abuse (including alcohol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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. |
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실험적: 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.
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In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Glycemic levels
기간: before meal and 30 and 60 minutes after meal
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Pre- and Post-prandial (before meal and 30 and 60 minutes after meal) blood glucose test
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before meal and 30 and 60 minutes after meal
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fatty Acid Composition
기간: Study Days:1,21,43 and 63
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ω3 incorporation into blood cell membranes(RBC)
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Study Days:1,21,43 and 63
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C-Reactive protein
기간: Study Days:1, 21, 43 and 63
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measures associated with CVD (Cardiovascular disease) risks
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Study Days:1, 21, 43 and 63
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MDA(Malondialdehyde)
기간: Study days: 1,21,43 and 63
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Measures associated with CVD (Cardiovascular disease) risks
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Study days: 1,21,43 and 63
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공동 작업자 및 조사자
수사관
- 수석 연구원: Pierre Singer, Professor,MD, ICU dep't, Institute for Nutrition Research, Rabin MC
- 연구 의자: Niva Shapiro, Ph.D.,R.D., Institute for Nutrition Research, Rabin MC
- 연구 책임자: Milana Grinev, Study Coordinator, ICU dep't, Institute for Nutrition Research, Rabin MC
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 6445
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