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

May 9, 2011 updated by: University of Reading

Acute Elevation of Non-esterified Fatty Acids on Endothelial Function and Insulin Sensitivity: A Comparison of Saturated and Long Chain n-3 Polyunsaturated Fatty Acids During the Postprandial Phase

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SFA
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).
Dietary supplement: Absence or presence of fish oil
Oral dose of saturated fat with or without fish oil and a heparin infusion
Experimental: SFA + LC n-3 PUFA
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).
Dietary supplement: Absence or presence of fish oil
Oral dose of saturated fat with or without fish oil and a heparin infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flow-mediated dilatation
Time Frame: Change from baseline to 240 min
Change from baseline to 240 min
Flow-mediated dilatation
Time Frame: Change from 240 min to 390 min
Change from 240 min to 390 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Digital volume pulse
Time Frame: Change from baseline to 240 min
Change from baseline to 240 min
Laser Doppler iontophoresis
Time Frame: Change from baseline to 240 min
Change from baseline to 240 min
Insulin sensitivity
Time Frame: 390 min
390 min
NEFA composition
Time Frame: Change from baseline to 240 min
Change from baseline to 240 min
Circulating endothelial function markers
Time Frame: Change from baseline to 240 min
Change from baseline to 240 min
Digital volume pulse
Time Frame: Change from 240 min to 390 min
Change from 240 min to 390 min
Laser Doppler iontophoresis
Time Frame: Change from 240 min to 390 min
Change from 240 min to 390 min
Circulating endothelial markers
Time Frame: Change from 240 min to 390 min
Change from 240 min to 390 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Biotechnology and Biological Sciences Research Council
Unilever R&D
Foundation for Research Science and Technology (New Zealand)

Investigators

  • Principal Investigator: Christine M Williams, University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMW-BB/E021816/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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