Skip to main content
OpenTrials
Completed

NCT Number: NCT01522482

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Impact of APOE genotype and dietary fat composition in plasma lipids

    Time frame: 3 months

Secondary outcomes

  1. Cardiovascular disease risk factors

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Unilever R&D

Registry information

Official study title

Effects of Meal Fatty Acid Composition on Postprandial Lipaemia in Men According to APOE Genotype

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Jan 31, 2012
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.