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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00631085
Acronym
GammaTox
Enrollment
18
Registered
2008-03-07
Start date
2008-05-31
Completion date
2009-07-31
Last updated
2011-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy nonsmoking nonasthmatic volunteers

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.

Interventions

Maxi Gamma softgels 1200mg QD

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy nonsmoking volunteers with normal lung function

Exclusion criteria

* Chronic illness * Asthma * Active allergies

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026