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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Petach Tikva, Israël, 49100
- Rabin Medical Center, Campus Beilinson
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune 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. |
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Glycemic levels
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fatty Acid Composition
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pierre Singer, Professor,MD, ICU dep't, Institute for Nutrition Research, Rabin MC
- Chaise d'étude: Niva Shapiro, Ph.D.,R.D., Institute for Nutrition Research, Rabin MC
- Directeur d'études: Milana Grinev, Study Coordinator, ICU dep't, Institute for Nutrition Research, Rabin MC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 6445
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