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

University of Reading

Status: Completed

Conditions: Cardiovascular Risk Factors

Treatments: Dietary Supplement: Absence or presence of fish oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01351324

CMW-BB/E021816/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

59 participants in 2 patient groups

SFA

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Absence or presence of fish oil

SFA + LC n-3 PUFA

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Absence or presence of fish oil