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

• ClinicalTrials.gov Identifier: NCT00631085
• Recruitment Status: Completed
• First Posted: March 7, 2008
• Last Update Posted: April 18, 2011
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by: University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: gamma tocopherol	Phase 1

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
1	Drug: gamma tocopherol; Maxi Gamma softgels 1200mg QD

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy nonsmoking volunteers with normal lung function

Exclusion Criteria:

• Chronic illness
• Asthma
• Active allergies

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina CEMALB

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Michelle Hernandez, MD; University of North Carolina

More Information

• Responsible Party: Michelle Hernandez, MD, UNC_Chapel Hill
• ClinicalTrials.gov Identifier: NCT00631085 History of Changes
• Other Study ID Numbers: GCRC 2678 IRB 08-0082; 5P01AT002620 ( U.S. NIH Grant/Contract )
• First Posted: March 7, 2008
• Last Update Posted: April 18, 2011
• Last Verified: April 2011

Keywords provided by University of North Carolina, Chapel Hill:

healthy nonsmoking nonasthmatic volunteers

Additional relevant MeSH terms:

Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; gamma-Tocopherol; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Nutrients; Growth Substances