Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects (Gammadose)

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

Study Overview

• Status: Completed
• Conditions: Gamma Tocopherol Serum Levels
• Intervention / Treatment: Dietary supplement: Gamma tocopherol

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Center for Environmental Medicine, Asthma and Lung Biology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gamma Tocopherol; Subjects will ingest 1400 mg gamma tocopherol, orally administered in 3 doses separated by 12 hours.	Dietary supplement: Gamma tocopherol; 3 doses of 1400 mg gamma tocopherol (2 capsules, each is 700mg), at 12 hour intervals; Other Names: Vitamin E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in gamma tocopherol serum levels	Baseline, 30 hours after initial dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in gamma-CEHC	Baseline, 30 hours after dosing initial dosing
Change in 5-NO-gamma tocopherol	Baseline, 30 hours after dosing initial dosing
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	Baseline, 30 hours after initial dosing

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: David B. Peden, MD, MS, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Tocotrienols; gamma-Tocopherol
• Other Study ID Numbers: 15-1291; 5R01ES023349-03 (U.S. NIH Grant/Contract)