Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults (GammaTox)
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ClinicalTrials.gov Identifier: NCT00631085 |
Recruitment Status :
Completed
First Posted : March 7, 2008
Last Update Posted : April 18, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: gamma tocopherol | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
1 |
Drug: gamma tocopherol
Maxi Gamma softgels 1200mg QD |
- The primary goal of this study is to determine the effect of γT on endotoxin-induced airway inflammation in non-allergic, non-asthmatic subjects. [ Time Frame: CCRE challenge after 7 days of treatment with gT or SO ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy nonsmoking volunteers with normal lung function
Exclusion Criteria:
- Chronic illness
- Asthma
- Active allergies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631085
United States, North Carolina | |
University of North Carolina CEMALB | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Michelle Hernandez, MD | University of North Carolina |
Responsible Party: | Michelle Hernandez, MD, UNC_Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00631085 |
Other Study ID Numbers: |
GCRC 2678 IRB 08-0082 5P01AT002620 ( U.S. NIH Grant/Contract ) |
First Posted: | March 7, 2008 Key Record Dates |
Last Update Posted: | April 18, 2011 |
Last Verified: | April 2011 |
healthy nonsmoking nonasthmatic volunteers |
Tocopherols Vitamin E Tocotrienols alpha-Tocopherol gamma-Tocopherol Antioxidants |
Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients |