Clinical trial NCT02610829: Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects
Official title: Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gamma Tocopherol Serum Levels
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2015-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate serum levels of gamma tocopherol and it's metabolites after 3 doses, each separated by 12 hours.

Detailed description: In previous studies the investigators have demonstrated that gamma-tocopherol-enriched (yT) supplementation decreased systemic oxidative stress, increased serum levels of yT, and inhibited monocyte responses to LPS without any adverse health effects. Free Radic Biol Med. 2008 Jul 1;45(1):40-9. doi: 10.1016/j.freeradbiomed.2008.03.002. Epub 2008 Mar 12.

Oxidant stress plays an important role in mucosal inflammation. Oxidant stress occurs individuals after exposure to air pollution, including high levels of ozone, LPS exposure and woodsmoke particle exposure. Potential exposure to all of these are naturally occurring events. Previous studies have also shown that asthmatic individuals tend to have lower endogenous levels of antioxidants such a s vitamins E and C, and that supplementing antioxidants can decrease exacerbation's associated with ozone exposure in children. The investigators are interested in future studies to examine the benefits of a rapid gamma tocopherol supplement in individuals who will be exposed to air pollution, either in a controlled chamber study or in a real life event, such as during high O3 days or when a woodsmoke fire is in their neighborhood.

This study is to address the question: can the investigators see an increase in serum levels of gT with a shorter course of gT supplementation? Additionally, before embarking on other investigations of gT as a potential prophylactic supplement, it is prudent to determine is discernible levels can be achieved with a shorter dose of gT.

Eligibility criteria: Inclusion Criteria:

1. Males and females between 18 and 50 years of age.
2. Vital signs within normal limits on admission to the study: SpO2 \> 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.

Exclusion Criteria:

1. Any chronic medical condition considered by the PI as a contraindication to receiving yT, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
2. Use of systemic or inhaled steroids.
3. Use of NSAID or ASA within 48 hours of dosing, and inability to withhold these medications for the duration of the study.
4. Use of anticoagulants including warfarin, heparin, clopidogrel or enoxaparin.
5. Diagnosis of anemia or abnormal blood counts at screening
6. Known vagal response to venipuncture
7. Abnormal PT or PTT values at screening.
8. BMI \> 35
9. Pregnant or breast feeding women will not be included.

Primary outcomes:
measure: Change in gamma tocopherol serum levels
timeFrame: Baseline, 30 hours after initial dosing
Secondary outcomes:
measure: Change in gamma-CEHC
timeFrame: Baseline, 30 hours after dosing initial dosing
measure: Change in 5-NO-gamma tocopherol
timeFrame: Baseline, 30 hours after dosing initial dosing
measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
timeFrame: Baseline, 30 hours after initial dosing
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: David B. Peden, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiser J, Alexis NE, Jiang Q, Wu W, Robinette C, Roubey R, Peden DB. In vivo gamma-tocopherol supplementation decreases systemic oxidative stress and cytokine responses of human monocytes in normal and asthmatic subjects. Free Radic Biol Med. 2008 Jul 1;45(1):40-9. doi: 10.1016/j.freeradbiomed.2008.03.002. Epub 2008 Mar 12.