- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01522482
Apolipoprotein (APO)E Genotype, Meal Fatty Acids, Postprandial Lipaemia
Effects of Meal Fatty Acid Composition on Postprandial Lipaemia in Men According to APOE Genotype
Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK. Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying particles), in particular low density lipoproteins (LDL) in circulation, is one of the most important physiological defects contributing to the development of CVD.
The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE genotype, with E4 individuals (25% of the UK population) being most responsive to changes in dietary fats, showing greater reductions when low levels of saturated fats or fish oils are consumed and greater increases when high levels of these fats are consumed. Therefore the aims of the present study is to understand the mechanism that regulates the higher LDLC response associated with saturated fatty acids and fish oil consumption in healthy men prospectively recruited based on their APOE genotype.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Reading, Storbritannia
- Department of Food and Nutritional Sciences, University of Reading
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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:
- Gender Male
- Age 18-70 years
- Body Mass Index (BMI) < 32 kg/m2
- Plasma triglycerides 1-4 mmol/l
- Plasma cholesterol < 8 mmol/l
- Glucose < 7 mmol/l
- Haemoglobin > 11 g/dl
- ApoE E3/E3, E3/E4
Exclusion Criteria:
- Blood pressure > 200/95 mmHg
- Had suffered a myocardial infraction or stroke in previous 2 years.
- Diabetes mellitus
- Liver disease
- Other endocrine disorders
- Unstable angina
- Familial hyperlipidaemia
- Any dietary restrictions or an a weight reducing diet
- On fatty acid supplements e.g. evening primrose oil or fish oils
- Vigorous exercise e.g. competitive athletes
- ApoE2/E2, apoE2/E3 and apoE2/E4
- Any other parameter on which the investigators felt an individual was unsuitable
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: High saturated fat meal
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Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats.
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Eksperimentell: Saturated fatty acid and fish oils meal
Equivalent to two portions of oily fish
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Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats and fish oil. The dose of fish oils was equivalent to two portions of oily fish. |
Aktiv komparator: High unsaturated fat meal
Provided a fatty acid profile representative of a typical UK diet
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Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for unsaturated fats.
It provided a fatty acid profile representative of a typical UK diet.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Impact of APOE genotype and dietary fat composition in plasma lipids
Tidsramme: 3 months
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3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Cardiovascular disease risk factors
Tidsramme: 3 months
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3 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Calabuig-Navarro MV, Jackson KG, Kemp CF, Leake DS, Walden CM, Lovegrove JA, Minihane AM. A randomized trial and novel SPR technique identifies altered lipoprotein-LDL receptor binding as a mechanism underlying elevated LDL-cholesterol in APOE4s. Sci Rep. 2017 Mar 9;7:44119. doi: 10.1038/srep44119.
- Calabuig-Navarro MV, Jackson KG, Walden CM, Minihane AM, Lovegrove JA. Apolipoprotein E genotype has a modest impact on the postprandial plasma response to meals of varying fat composition in healthy men in a randomized controlled trial. J Nutr. 2014 Nov;144(11):1775-80. doi: 10.3945/jn.114.197244. Epub 2014 Sep 17.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 08/31
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