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

NCT00631085 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-04-18

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

gamma tocopherol

Maxi Gamma softgels 1200mg QD

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michelle Hernandez, MD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631085 on ClinicalTrials.gov