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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522482
• Other study ID #: 08/31
• Status: Completed
• Phase: N/A
• First received: January 26, 2012
• Last updated: January 31, 2012
• Start date: March 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of APOE genotype and dietary fat composition in plasma lipids		3 months	No
Secondary	Cardiovascular disease risk factors		3 months	No