Clinical trial NCT01522482: Apolipoprotein (APO)E Genotype, Meal Fatty Acids, Postprandial Lipaemia
Official title: Effects of Meal Fatty Acid Composition on Postprandial Lipaemia in Men According to APOE Genotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: fatty acids
cardiovascular disease
genotype
apoE
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2012-01-31
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Impact of APOE genotype and dietary fat composition in plasma lipids
timeFrame: 3 months
Secondary outcomes:
measure: Cardiovascular disease risk factors
timeFrame: 3 months
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences, University of Reading
Study officials:
affiliation: University of Reading
name: Julie A Lovegrove, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.