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

This study has been completed.
Sponsor:
Collaborators:
Biotechnology and biological science research council
Unilever R&D
Foundation for Research Science and Technology (New Zealand)
Information provided by:
University of Reading
ClinicalTrials.gov Identifier:
NCT01351324
First received: May 6, 2011
Last updated: May 9, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Cardiovascular Risk Factors
 Dietary Supplement: Absence or presence of fish oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Flow-mediated dilatation [ Time Frame: Change from baseline to 240 min ] [ Designated as safety issue: No ]
  • Flow-mediated dilatation [ Time Frame: Change from 240 min to 390 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Digital volume pulse [ Time Frame: Change from baseline to 240 min ] [ Designated as safety issue: No ]
  • Laser Doppler iontophoresis [ Time Frame: Change from baseline to 240 min ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: 390 min ] [ Designated as safety issue: No ]
  • NEFA composition [ Time Frame: Change from baseline to 240 min ] [ Designated as safety issue: No ]
  • Circulating endothelial function markers [ Time Frame: Change from baseline to 240 min ] [ Designated as safety issue: No ]
  • Digital volume pulse [ Time Frame: Change from 240 min to 390 min ] [ Designated as safety issue: No ]
  • Laser Doppler iontophoresis [ Time Frame: Change from 240 min to 390 min ] [ Designated as safety issue: No ]
  • Circulating endothelial markers [ Time Frame: Change from 240 min to 390 min ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351324

Locations
United Kingdom
University of Reading
Reading, United Kingdom
Sponsors and Collaborators
University of Reading
Biotechnology and biological science research council
Unilever R&D
Foundation for Research Science and Technology (New Zealand)
Investigators
Principal Investigator: Christine M Williams University of Reading
  More Information

No publications provided by University of Reading

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Christine Williams, University of Reading
ClinicalTrials.gov Identifier: NCT01351324     History of Changes
Other Study ID Numbers: CMW-BB/E021816/1
Study First Received: May 6, 2011
Last Updated: May 9, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Reading:
Endothelial function
Non-esterified fatty acids
Insulin sensitivity

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013