Apolipoprotein (APO)E Genotype, Meal Fatty Acids, Postprandial Lipaemia

NCT01522482 | Completed DMC

• 1 other identifier: 08/31
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

fatty acids; cardiovascular disease; genotype; apoE

Outcome Measures

Primary Outcomes (1)

• Impact of APOE genotype and dietary fat composition in plasma lipids

  3 months

Secondary Outcomes (1)

• Cardiovascular disease risk factors

  3 months

Study Arms (3)

High saturated fat meal

EXPERIMENTAL

Dietary Supplement: High saturated fat meal

Saturated fatty acid and fish oils meal

EXPERIMENTAL

Equivalent to two portions of oily fish

Dietary Supplement: Saturated fatty acids and fish oil meal

High unsaturated fat meal

ACTIVE COMPARATOR

Provided a fatty acid profile representative of a typical UK diet

Dietary Supplement: High unsaturated fat meal

Interventions

High saturated fat meal DIETARY_SUPPLEMENT

Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats.

High saturated fat meal

Saturated fatty acids and fish oil meal DIETARY_SUPPLEMENT

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.

Saturated fatty acid and fish oils meal

High unsaturated fat meal DIETARY_SUPPLEMENT

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.

High unsaturated fat meal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Unilever R&D: collaborator

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28276521 DERIVED

• 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.

  PMID: 25332476 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fatty Acids

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

• Julie A Lovegrove, Professor

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-01

Locations

GB (1)