Ischemia Reperfusion: Prostaglandins and Antioxidants

Not Applicable

Completed

• Conditions: Ischemic Reperfusion Injury
• Interventions: Dietary Supplement: Antioxidant; Drug: Prostaglandin inhibitor (Ibuprophen)

• Registration Number: NCT01666587
• Lead Sponsor: University of Essex

Brief Summary

The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Primary Completion: 2013-04
• Study Completion: 2013-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy males
• Healthy females

Exclusion Criteria

• Smokers
• Cardiovascular disease
• Peripheral vascular disease
• Neurological deficits
• Diabetes Type I or II
• Pregnant women
• Adverse reactions to Ibuprofen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Antioxidant load	Antioxidant	Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery
Prostaglandin inhibition	Prostaglandin inhibitor (Ibuprophen)	Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery
Combined	Antioxidant	Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery
Combined	Prostaglandin inhibitor (Ibuprophen)	Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery

Primary Outcome Measures

Name	Time	Method
Change in flow mediated dilation	Change from baseline at 15 minutes after ischemia-reperfusion injury	Flow mediated dilation is a measure of vascular function and is measured as the outcome before and after an injury to the inner lining of the artery.

Secondary Outcome Measures

Name	Time	Method
Change in low flow mediated constriction	Change from baseline at 15 minutes after ischemia-reperfusion injury	low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury

Trial Locations

Locations (1)

University of Essex; 🇬🇧 Colchester, Essex, United Kingdom