A Study of Different Types of Fatty Acid on Risk Factors for Heart Disease

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factors
• Interventions: Dietary Supplement: Absence or presence of fish oil

• Registration Number: NCT01351324
• Lead Sponsor: University of Reading

Brief Summary

Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and insulin sensitivity but the impact of NEFA composition is unknown.

The objective was to test the effect of acute elevation of NEFA enriched with either saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.

Detailed Description

To investigate potential diet-gene interactions, potential subjects (n=370) were prospectively genotyped for the eNOS Glu298Asp polymorphism, of which 35 were Asp298 and 150 were Glu298 homozygotes. Three subjects in the Asp298 group were unable to participate, two were unsuitable according to selection criteria and one subject subsequently withdrew from the study. Subjects homozygous for Asp298 (n=29) and Glu298 (n=30) were therefore selected, balanced for gender, age and BMI.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-01
• Study Completion: 2010-05
• Status Verified: 2011-04
• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-09
• Last Update Submitted: 2011-05-09
• Study First Posted: 2011-05-10
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Healthy
• Either homozygous for eNOS Glu298 (wildtype)or eNOS Asp298 (variant)

Exclusion Criteria

• Smokers
• Raised fasting blood lipids
• Taking excessive fish oil supplements (>1g EPA/DHA per day)
• Taking medication known to influence blood lipids, blood pressure or blood clotting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SFA + LC n-3 PUFA	Absence or presence of fish oil	Oral dose of palmitic acid and DHA-rich fish oil (SFA + LC n-3 PUFA) given as a chocolate-flavoured drink every 30 min (0-390 min) together with a continuous infusion of heparin (60-390 min).
SFA	Absence or presence of fish oil	Oral dose of palmitic acid (SFA) given as a chocolate-flavoured drink every 30 min (0-390 min) with a continuous infusion of heparin (60-390 min).

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilatation	Change from 240 min to 390 min

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity	390 min
Digital volume pulse	Change from 240 min to 390 min
NEFA composition	Change from baseline to 240 min
Circulating endothelial function markers	Change from baseline to 240 min
Laser Doppler iontophoresis	Change from 240 min to 390 min
Circulating endothelial markers	Change from 240 min to 390 min

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, United Kingdom