Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects

NCT02610829 | Completed

• 2 other identifiers: 15-12915R01ES023349-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gamma Tocopherol Serum Levels

Outcome Measures

Primary Outcomes (1)

• Change in gamma tocopherol serum levels

  Baseline, 30 hours after initial dosing

Secondary Outcomes (3)

• 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

Study Arms (1)

Gamma Tocopherol

EXPERIMENTAL

Subjects will ingest 1400 mg gamma tocopherol, orally administered in 3 doses separated by 12 hours.

Dietary Supplement: Gamma tocopherol

Interventions

Gamma tocopherol DIETARY_SUPPLEMENT

3 doses of 1400 mg gamma tocopherol (2 capsules, each is 700mg), at 12 hour intervals

Also known as: Vitamin E

Gamma Tocopherol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females between 18 and 50 years of age.
• 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.

You may not qualify if:

• 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.
• Use of systemic or inhaled steroids.
• Use of NSAID or ASA within 48 hours of dosing, and inability to withhold these medications for the duration of the study.
• Use of anticoagulants including warfarin, heparin, clopidogrel or enoxaparin.
• Diagnosis of anemia or abnormal blood counts at screening
• Known vagal response to venipuncture
• Abnormal PT or PTT values at screening.
• BMI \> 35
• Pregnant or breast feeding women will not be included.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 18405673 RESULT

MeSH Terms

Interventions

gamma-Tocopherol; Vitamin E

Intervention Hierarchy (Ancestors)

Tocopherols; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David B. Peden, MD, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

US (1)