Ischemia Reperfusion: Prostaglandins and Antioxidants

Study Overview
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Brief Summary
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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?

Official Title
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The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans

Conditions
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Ischemic Reperfusion Injury

Intervention / Treatment
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* Dietary Supplement: Antioxidant
* Drug: Prostaglandin inhibitor (Ibuprophen)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Control trial to determine the impact of the ischemic injury on vascular function without intervention | |
| Experimental: Antioxidant load<br>Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery | Dietary Supplement: Antioxidant<br> <br> |
| Experimental: Prostaglandin inhibition<br>Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery | Drug: Prostaglandin inhibitor (Ibuprophen)<br> <br> * Other names: ibuprofen;|
| Experimental: Combined<br>Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery | Dietary Supplement: Antioxidant<br> <br> Drug: Prostaglandin inhibitor (Ibuprophen)<br> <br> * Other names: ibuprofen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in flow mediated dilation | 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. | Change from baseline at 15 minutes after ischemia-reperfusion injury | 

Secondary Outcome Measures

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