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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

May 6, 2011
May 9, 2011
March 2009
January 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01351324 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Different Types of Fatty Acid on Risk Factors for Heart Disease
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Cardiovascular Risk Factors
Dietary Supplement: Absence or presence of fish oil
Oral dose of saturated fat with or without fish oil and a heparin infusion
  • 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).
    Intervention: Dietary Supplement: Absence or presence of fish oil
  • 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).
    Intervention: Dietary Supplement: Absence or presence of fish oil
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. Epub 2011 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
May 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01351324
CMW-BB/E021816/1
No
Professor Christine Williams, University of Reading
University of Reading
  • Biotechnology and biological science research council
  • Unilever R&D
  • Foundation for Research Science and Technology (New Zealand)
Principal Investigator: Christine M Williams University of Reading
University of Reading
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP