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

Cardiovascular Risk Factors Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351324
• Other study ID #: CMW-BB/E021816/1
• Status: Completed
• Phase: N/A
• First received: May 6, 2011
• Last updated: May 9, 2011
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2011
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Risk Factors

Intervention

Dietary Supplement:
• Absence or presence of fish oil
Oral dose of saturated fat with or without fish oil and a heparin infusion

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilatation		Change from baseline to 240 min	No
Primary	Flow-mediated dilatation		Change from 240 min to 390 min	No
Secondary	Digital volume pulse		Change from baseline to 240 min	No
Secondary	Laser Doppler iontophoresis		Change from baseline to 240 min	No
Secondary	Insulin sensitivity		390 min	No
Secondary	NEFA composition		Change from baseline to 240 min	No
Secondary	Circulating endothelial function markers		Change from baseline to 240 min	No
Secondary	Digital volume pulse		Change from 240 min to 390 min	No
Secondary	Laser Doppler iontophoresis		Change from 240 min to 390 min	No
Secondary	Circulating endothelial markers		Change from 240 min to 390 min	No