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

This study has been completed.
Sponsor:
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier:
NCT01522482
First received: January 26, 2012
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Dietary Supplement: High saturated fat meal
Dietary Supplement: Saturated fatty acids and fish oil meal
Dietary Supplement: High unsaturated fat meal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Meal Fatty Acid Composition on Postprandial Lipaemia in Men According to APOE Genotype

Resource links provided by NLM:


Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Impact of APOE genotype and dietary fat composition in plasma lipids [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular disease risk factors [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2009
Study Completion Date: July 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High saturated fat meal Dietary Supplement: 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
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.

Active Comparator: High unsaturated fat meal
Provided a fatty acid profile representative of a typical UK diet
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522482

Locations
United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, United Kingdom
Sponsors and Collaborators
University of Reading
Unilever R&D
Investigators
Principal Investigator: Julie A Lovegrove, Professor University of Reading
  More Information

No publications provided

Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01522482     History of Changes
Other Study ID Numbers: 08/31
Study First Received: January 26, 2012
Last Updated: January 31, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Reading:
fatty acids
cardiovascular disease
genotype
apoE

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014