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

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ClinicalTrials.gov Identifier: NCT01351324
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : May 10, 2011
Sponsor:
Collaborators:
Information provided by:

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.


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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : March 2009
Primary Completion Date : January 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Flow-mediated dilatation [ Time Frame: Change from baseline to 240 min ]
  2. Flow-mediated dilatation [ Time Frame: Change from 240 min to 390 min ]

Secondary Outcome Measures :
  1. Digital volume pulse [ Time Frame: Change from baseline to 240 min ]
  2. Laser Doppler iontophoresis [ Time Frame: Change from baseline to 240 min ]
  3. Insulin sensitivity [ Time Frame: 390 min ]
  4. NEFA composition [ Time Frame: Change from baseline to 240 min ]
  5. Circulating endothelial function markers [ Time Frame: Change from baseline to 240 min ]
  6. Digital volume pulse [ Time Frame: Change from 240 min to 390 min ]
  7. Laser Doppler iontophoresis [ Time Frame: Change from 240 min to 390 min ]
  8. Circulating endothelial markers [ Time Frame: Change from 240 min to 390 min ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351324


Locations
United Kingdom
University of Reading
Reading, United Kingdom
Sponsors and Collaborators
University of Reading
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
More Information

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
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: April 2011

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
Heparin
Insulin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs