Measurement of Biomarkers in Samples Collected in a Coenzyme Q10 Treatment Trial in Gulf War Illness and Control Subjects
Abstract
The project originally was a partnership of a clinician, Dr. Klimas, and a laboratory scientist, Dr. Fletcher. After Dr. Fletcher's retirement, Dr. Abreu took over the PI role in which the goal is 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 affect the biomarker signature found in GWI patients. Specifically, we seek to perform biomarker analysis before and after two, four, and six months of therapy with blood collections from subjects in the clinical trial. Laboratory assessments consists of plasma cytokines, natural killer cell function, plasma levels of neuropeptide Y, immune- phenotyping studies using flow cytometry, and mitochondrial function. This data will then be used to correlate these biomarkers with symptom clusters, illness severity and their usefulness in predicting responders to the intervention. Recruitment is closed 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 100 participants. As this is a blind, randomized trial, we cannot compare the participants treated with CoQ10 (200mg) to the matched GWI participant placebo group until the end of the study, though we have a growing data set for the cohorts. The final subject completed the study drug at the end of October; batched assays are now being completed. We have sent data for analysis and link biomarker changes with clinical response to our BU colleagues who are also managing the VA Merit trial data set. Final analysis and manuscript submission should be complete by Spring 2022.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1168084
Entities
People
- Maria Abreu
- Nancy G. Klimas
Organizations
- South Florida Veterans Affairs Foundation for Research and Education