- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Reading, Storbritannien
- Department of Food and Nutritional Sciences, University of Reading
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: High saturated fat meal
|
Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats.
|
Experimentell: Saturated fatty acid and fish oils meal
Equivalent to two portions of oily fish
|
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
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Impact of APOE genotype and dietary fat composition in plasma lipids
Tidsram: 3 months
|
3 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Cardiovascular disease risk factors
Tidsram: 3 months
|
3 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 08/31
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på High saturated fat meal
-
Hvidovre University HospitalUniversity of Copenhagen; Danish Research Centre for Magnetic ResonanceAvslutadDiabetes | Metaboliskt syndrom | NAFLD | Övervikt och fetmaDanmark