Postprandial Response After Intake of Meals With Different Fatty Acid Composition
29. juni 2016 opdateret af: Kirsten Holven, University of Oslo
Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Post box 1046, Blindern
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Oslo, Post box 1046, Blindern, Norge, 0317
- University of Oslo
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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 30 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 18 - 30 years of age
Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are:
- Untreated
- Treated with low dose statin (<20 mg atorvastatin, <10-20 mg simvastatin or <5-10 mg rosuvastatin)
- Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period)
- Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period)
- BMI 18.5 - 30 kg/m2
- Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight)
Exclusion Criteria:
- CRP >10 mg/L
- TG >4 mmol/L
- Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism
- Pregnant or lactating
- Allergic or intolerant to gluten or egg
- Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits
- Using medications affecting lipid metabolism or inflammation, except statins for FH subjects
- Hormone treatment (except contraception and thyroxin (stabile dose last 3 months))
- Donating blood 2 months within or during study period
- Tobacco smoking
- Large alcohol consumption (>40g daily)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Familial hypercholesterolemia
Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
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Muffin rich in saturated fat.
Muffin rich in polyunsaturated fat.
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Aktiv komparator: Healthy
Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline
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Muffin rich in saturated fat.
Muffin rich in polyunsaturated fat.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in levels of circulating triglycerides
Tidsramme: Measured at baseline and 2,4 and 6 hours after intake of test meal
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Measured at baseline and 2,4 and 6 hours after intake of test meal
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Changes in markers of lipid- and glucose metabolism
Tidsramme: Measured at baseline and 2,4 and 6 hours after intake of test meal
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Changes in levels of total cholesterol, low-density lipoprotein, high-density lipoprotein, apolipoprotein (apo) B, apo A1, apo CIII, apo B48, lipoprotein (a), free fatty acids, total fatty acid composition, LDL-receptor-related protein with 11 ligand-binding repeats (LR11), HbA1c, glucose, insulin and troponin.
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Measured at baseline and 2,4 and 6 hours after intake of test meal
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Changes in circulating levels of inflammatory markers
Tidsramme: Measured at baseline and 2,4 and 6 hours after intake of test meal
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Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP
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Measured at baseline and 2,4 and 6 hours after intake of test meal
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Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism
Tidsramme: Measured at baseline and 2, 4 and 6 hours after intake of test meal
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Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level
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Measured at baseline and 2, 4 and 6 hours after intake of test meal
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Changes in lipid classes and lipoprotein size
Tidsramme: Measured at baseline and 2,4 and 6 hours after intake of test meal
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Measured at baseline and 2,4 and 6 hours after intake of test meal
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Changes in plasma and urine metabolomics
Tidsramme: Measured in plasma at baseline and 2,4 and 6 hours after intake of test meal. Measured in urine at fasting state and during the 6 hour postprandial phase.
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Changes in metabolites such as glucose, lactate, pyruvate, citrate and amino acids will be measured in plasma and urine.
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Measured in plasma at baseline and 2,4 and 6 hours after intake of test meal. Measured in urine at fasting state and during the 6 hour postprandial phase.
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Check DNA for single nuclear polymorphisms
Tidsramme: Measured at baseline and 2,4 and 6 hours after intake of test meal
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Measured at baseline and 2,4 and 6 hours after intake of test meal
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Changes in PBMC Whole genome transcriptomics
Tidsramme: Measured at baseline and 4 and 6 hours after intake of test meal
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Measured at baseline and 4 and 6 hours after intake of test meal
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kirsten Bjørklund Holven, Professor, Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
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. marts 2016
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først indsendt
31. marts 2016
Først indsendt, der opfyldte QC-kriterier
5. april 2016
Først opslået (Skøn)
6. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015/2392/REK sør-øst B
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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