- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01565252
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Petach Tikva, Israel, 49100
- Rabin Medical Center, Campus Beilinson
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 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. |
|
Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Glycemic levels
Tidsramme: 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
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before meal and 30 and 60 minutes after meal
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fatty Acid Composition
Tidsramme: 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
Tidsramme: Study Days:1, 21, 43 and 63
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measures associated with CVD (Cardiovascular disease) risks
|
Study Days:1, 21, 43 and 63
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MDA(Malondialdehyde)
Tidsramme: Study days: 1,21,43 and 63
|
Measures associated with CVD (Cardiovascular disease) risks
|
Study days: 1,21,43 and 63
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Pierre Singer, Professor,MD, ICU dep't, Institute for Nutrition Research, Rabin MC
- Studiestol: Niva Shapiro, Ph.D.,R.D., Institute for Nutrition Research, Rabin MC
- Studieleder: Milana Grinev, Study Coordinator, ICU dep't, Institute for Nutrition Research, Rabin MC
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 6445
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