- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01389492
The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
6. juli 2011 opdateret af: Hadassah Medical Organization
Nutritional Study:The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers.
Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Jerusalem, Israel, 91120
- The Hebrew University of Jerusalem
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adults, normal BMI
Exclusion Criteria:
- Metabolic disorders
- Smokers
- Drinkers
- Taking nutritional supplement
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: frozen meat
250 g of frozen meat meal for 4 days
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
|
Andet: frozen meat and wine
250 g of frozen meat and red wine for 4 days
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
|
Andet: fresh meat
250 g of fresh meat meal
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
|
Andet: fresh meat and wine
250 g of fresh meat meal
|
250 g of meat cutlets
250 g of meat meal for 4 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in plasma MDA levels following meat meal
Tidsramme: Fasting before meal and 3, and 6 h postprandial, and fasting levels
|
After an overnight fast baseline (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes.
The subjects then ate a test meal within 30 min.
Blood samples (10 ml) were drawn 3 and 6 h after the meal was eaten.
Serum was separated from whole blood by centrifugation (910 g, 15 min), and MDA was evaluated by HPLC in plasma samples
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Fasting before meal and 3, and 6 h postprandial, and fasting levels
|
|
Changes in MDA concentration on LDL fraction following meat meals
Tidsramme: Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast
|
Subject consumed the test meals for 4 days.
Day 1, (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes.
The sbjects then ate a test meal within 30 min.
Blood samples (10 ml) were drawn 3 h after the meal was eaten.
Blood was collected at day 4, 3 h after the meal was eaten, at the morning of day 5.Plasma LDL was isolated using a single discontinuous density gradient ultracentrifugation.
The protein concentration was determined based on the method of Bradford.
MDA concentration was evaluated by HPLC.
|
Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Shlomit Gorelik, PhD, Hebrew University of Jerusalem
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2010
Primær færdiggørelse (Faktiske)
1. februar 2011
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
3. juli 2011
Først indsendt, der opfyldte QC-kriterier
6. juli 2011
Først opslået (Skøn)
8. juli 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juli 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2011
Sidst verificeret
1. oktober 2009
Mere information
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .