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

January 31, 2012 updated by: Julie Lovegrove, University of Reading

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reading, United Kingdom
        • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Experimental: 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.

Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of APOE genotype and dietary fat composition in plasma lipids
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular disease risk factors
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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