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

NCT ID: NCT01522482

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

High saturated fat meal

Group Type: EXPERIMENTAL

High saturated fat meal

Intervention Type: DIETARY_SUPPLEMENT

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

Saturated fatty acid and fish oils meal

Equivalent to two portions of oily fish

Group Type: EXPERIMENTAL

Saturated fatty acids and fish oil meal

Intervention Type: 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.

High unsaturated fat meal

Provided a fatty acid profile representative of a typical UK diet

Group Type: ACTIVE_COMPARATOR

High unsaturated fat meal

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Saturated fatty acids and fish oil meal

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.

Intervention Type: DIETARY_SUPPLEMENT

High unsaturated fat meal

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: collaborator

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Julie Lovegrove

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie A Lovegrove, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

Department of Food and Nutritional Sciences, University of Reading

Reading, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 28276521 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25332476 (View on PubMed)

Other Identifiers

08/31

Identifier Type: -

Identifier Source: org_study_id