search
Back to results

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

Primary Purpose

Cardiovascular Risk Factors

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Absence or presence of fish oil
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Risk Factors focused on measuring Endothelial function, Non-esterified fatty acids, Insulin sensitivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SFA

SFA + LC n-3 PUFA

Arm 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).

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).

Outcomes

Primary Outcome Measures

Flow-mediated dilatation
Flow-mediated dilatation

Secondary Outcome Measures

Digital volume pulse
Laser Doppler iontophoresis
Insulin sensitivity
NEFA composition
Circulating endothelial function markers
Digital volume pulse
Laser Doppler iontophoresis
Circulating endothelial markers

Full Information

First Posted
May 6, 2011
Last Updated
May 9, 2011
Sponsor
University of Reading
Collaborators
Biotechnology and Biological Sciences Research Council, Unilever R&D, Foundation for Research Science and Technology (New Zealand)
search

1. Study Identification

Unique Protocol Identification Number
NCT01351324
Brief Title
A Study of Different Types of Fatty Acid on Risk Factors for Heart Disease
Acronym
eFAIRE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Reading
Collaborators
Biotechnology and Biological Sciences Research Council, Unilever R&D, Foundation for Research Science and Technology (New Zealand)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors
Keywords
Endothelial function, Non-esterified fatty acids, Insulin sensitivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFA
Arm Type
Experimental
Arm 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).
Arm Title
SFA + LC n-3 PUFA
Arm Type
Experimental
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Absence or presence of fish oil
Intervention Description
Oral dose of saturated fat with or without fish oil and a heparin infusion
Primary Outcome Measure Information:
Title
Flow-mediated dilatation
Time Frame
Change from baseline to 240 min
Title
Flow-mediated dilatation
Time Frame
Change from 240 min to 390 min
Secondary Outcome Measure Information:
Title
Digital volume pulse
Time Frame
Change from baseline to 240 min
Title
Laser Doppler iontophoresis
Time Frame
Change from baseline to 240 min
Title
Insulin sensitivity
Time Frame
390 min
Title
NEFA composition
Time Frame
Change from baseline to 240 min
Title
Circulating endothelial function markers
Time Frame
Change from baseline to 240 min
Title
Digital volume pulse
Time Frame
Change from 240 min to 390 min
Title
Laser Doppler iontophoresis
Time Frame
Change from 240 min to 390 min
Title
Circulating endothelial markers
Time Frame
Change from 240 min to 390 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Williams
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Reading
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25921849
Citation
Newens KJ, Thompson AK, Jackson KG, Williams CM. Endothelial function and insulin sensitivity during acute non-esterified fatty acid elevation: Effects of fat composition and gender. Nutr Metab Cardiovasc Dis. 2015 Jun;25(6):575-81. doi: 10.1016/j.numecd.2015.03.004. Epub 2015 Mar 14.
Results Reference
derived
PubMed Identifier
21831993
Citation
Newens KJ, Thompson AK, Jackson KG, Wright J, Williams CM. DHA-rich fish oil reverses the detrimental effects of saturated fatty acids on postprandial vascular reactivity. Am J Clin Nutr. 2011 Sep;94(3):742-8. doi: 10.3945/ajcn.110.009233. Epub 2011 Aug 10.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs