Glutathione vs. Curcumin Clinical Trial

Overview

The investigator proposes to perform a phase I/II study comparing two nutraceuticals and placebo that target mediators identified in the investigator's prior dynamic modeling study of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment and on therapy to assess the modeling and the impact of the interventions on the homeostatic networks that have identified, with an added focus on the glutathione/redox system.

Full Title of Study: “Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: August 2019

Detailed Description

In the Investigator's prior study "Dynamic Modeling in GWI", the investigator used an exercise stress model (rest, peak oxygen consumption oxygen uptake, and 7 follow-up sampling points) to measure the mediators of relapse in the context of their interactive homeostatic networks. The investigator surveyed the response of genes and blood-borne biomarkers in order to interrogate and map regulation of neuro-endocrine-autonomic-immune function in these subjects as compared to GW era sedentary healthy controls. The investigator's research team applied an integrative systems-based approach rooted in computational biology connecting gene expression and biomarkers to pathways and to symptoms in order to identify potential therapeutic targets as well as optimal strategies for manipulation of these targets. Using this data the investigator's research team has developed a virtual model of the illness, which has been used to identify potential therapeutic targets.

Interventions

  • Drug: Curcumin
    • Perform a randomized phase I/II study comparing curcumin (increased bioavailable form, body cell mass-85, 400 mg twice a day) to glutathione (liposomal bioavailable form 630 mg bid), with a 3 month intervention and assessment of safety, efficacy and biomarker response to therapy.
  • Drug: Glutathione
    • Perform dynamic modeling studies before and after 3 months of therapy, repeating the method used previously in order to compare the response to exercise across groups and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies.
  • Other: Placebo
    • Placebo liquid 120 ml per/ bottle Placebo capsules 60 capsules per bottle 400 mg /cap With the addition of a Partner PI, redox/methylation expert Dr. Richard Deth, perform studies of antioxidant and methylation-related metabolic status prior to, during and after acute exercise in GWI subjects before and after interventions.

Arms, Groups and Cohorts

  • Experimental: Curcumin
    • 12 weeks 400mg orally twice a day
  • Experimental: Liposomal Glutathione
    • 12 weeks 630mg orally twice a day
  • Experimental: Placebo Liquid or Capsules
    • Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap

Clinical Trial Outcome Measures

Primary Measures

  • Biomarker response to therapy using a VO2 exercise test
    • Time Frame: 12 weeks
    • Goal is that both will prove safe for use in GWI patients
  • Biomarker response to therapy using cytokine panel
    • Time Frame: 12 weeks
    • Goal is that both will prove safe for use in GWI patients

Participating in This Clinical Trial

Inclusion Criteria

  • Veterans with Gulf War Illness
  • 35 to 70 years old
  • Good health by medical history prior to 1990
  • Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity

Exclusion Criteria

  • Major depression with psychotic or melancholic features
  • Schizophrenia
  • Bipolar disorder
  • Delusional disorders
  • Dementias of any type
  • History or current alcohol abuse
  • History or current drug abuse
  • Current tobacco use
  • Organ failure
  • Defined rheumatologic
  • Inflammatory disorders
  • HIV
  • Hepatitis B and C
  • Primary sleep disorders
  • Steroids
  • Immunosuppressives

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • South Florida Veterans Affairs Foundation for Research and Education
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nancy Klimas, M.D – South Florida Veterans Affairs Foundation for Research and Education
  • Overall Official(s)
    • Elizabeth Balbin, Study Director, Nova University
  • Overall Contact(s)
    • Fanny V Collado, RN, 305-575-7000, fanny.collado@va.gov

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.