Accession Number:

AD1094412

Title:

Measurement of Biomarkers in Samples Collected in a Coenzyme Q10 Treatment Trial in Gulf War Illness and Control Subjects

Descriptive Note:

Technical Report,30 Sep 2017,29 Sep 2018

Corporate Author:

South Florida VA Foundation for Research and Education Inc. Miami United States

Personal Author(s):

Report Date:

2018-10-01

Pagination or Media Count:

11.0

Abstract:

The current project is a partnership of a clinician, Dr. Klimas and a laboratory scientist, Dr. Fletcher to examine the usefulness of biomarkers in the treatment of GWI, and predicting the subgroup most responsive to an antioxidant intervention, ubiquinol. It is hypothesized that CoQ10 will favorably impact the biomarker signature found in GWI patients. Specifically, we seek to perform biomarker studies before and after two, four, and six months of therapy, with blood collections from subjects in the clinical trial and laboratory assessments of plasma cytokines, natural killer cell function, plasma neuropeptide Y, cell population studies by flow cytometry, and mitochondrial function and then to correlate these biomarkers with symptom clusters, illness severity and their usefulness in predicting responders to the intervention. Recruitment is ongoing in the Phase III placebo control treatment trial of CoQ10, which Is sponsored by the VA. In this collaborative DoD study, we are assessing the biomarkers pre and post-treatment from the plasma, serum, and PBMCs obtained from the 27 participants to date. As this is a blind, randomized trial, we cannot compare the participants treated with CoQ10 200mg compared to the matched GWI participant placebo group until the end of the study, though we have a growing data set of baseline data or the cohorts. Our timeline is tied to that of the ongoing clinical trial, which just entered the 2nd year of a 3 year timeline. In this first year, we have successfully worked out the logistics of obtaining and processing samples from the 4 sites and linking data to the clinical assessment data set. We have adjusted our anticipated spending to reserve funding for an anticipated continuation year, based on the timeline of the VA based clinical trial.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE