NCT01351324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
Last Updated

May 10, 2011

Status Verified

April 1, 2011

Enrollment Period

10 months

First QC Date

May 6, 2011

Last Update Submit

May 9, 2011

Conditions

Cardiovascular Risk Factors

Keywords

Endothelial functionNon-esterified fatty acidsInsulin sensitivity

Outcome Measures

Primary Outcomes (2)

  • Flow-mediated dilatation

    Change from baseline to 240 min

  • Flow-mediated dilatation

    Change from 240 min to 390 min

Secondary Outcomes (8)

  • Digital volume pulse

    Change from baseline to 240 min

  • Laser Doppler iontophoresis

    Change from baseline to 240 min

  • Insulin sensitivity

    390 min

  • NEFA composition

    Change from baseline to 240 min

  • Circulating endothelial function markers

    Change from baseline to 240 min

  • +3 more secondary outcomes

Study Arms (2)

SFA

EXPERIMENTAL

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

SFA + LC n-3 PUFA

EXPERIMENTAL

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

Interventions

Absence or presence of fish oilDIETARY_SUPPLEMENT

Oral dose of saturated fat with or without fish oil and a heparin infusion

SFASFA + LC n-3 PUFA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Either homozygous for eNOS Glu298 (wildtype)or eNOS Asp298 (variant)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 25921849DERIVED

  • 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.

    PMID: 21831993DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Christine M Williams

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 10, 2011

Study Start

March 1, 2009

Primary Completion

January 1, 2010

Study Completion

May 1, 2010

Last Updated

May 10, 2011

Record last verified: 2011-04

Locations

GB(1)