Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: gamma tocopherol

• Registration Number: NCT00631085
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol) will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT), another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet, but is the major form in blood and tissue. It is also the major form of Vitamin E in over-the-counter supplements. However, gT has anti-inflammatory properties which are not present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in animal studies, and previous studies have shown levels of gT are inversely associated with heart disease.

We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin units) we will see an increase in the number of neutrophils (a type of white blood cell that your body produces to fight infection) in your lung cells without causing you to have flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells after the endotoxin challenge when you take the gT versus when you take a placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Study Start: 2008-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy nonsmoking volunteers with normal lung function

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Exclusion Criteria

• Chronic illness
• Asthma
• Active allergies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	gamma tocopherol	-

Primary Outcome Measures

Name	Time	Method
The primary goal of this study is to determine the effect of γT on endotoxin-induced airway inflammation in non-allergic, non-asthmatic subjects.	CCRE challenge after 7 days of treatment with gT or SO

Trial Locations

Locations (1)

University of North Carolina CEMALB; 🇺🇸 Chapel Hill, North Carolina, United States