Glutathione vs. Curcumin Clinical Trial
Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin
  • Phase

    Phase 1/Phase 2
  • Study Type

  • Status

    Unknown status
  • Study Participants

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.
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.
Study Started
Apr 30
Primary Completion
Aug 31
Study Completion
Aug 31
Last Update
Jan 29

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.

Curcumin Experimental

12 weeks 400mg orally twice a day

Liposomal Glutathione Experimental

12 weeks 630mg orally twice a day

Placebo Liquid or Capsules Experimental

Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap


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
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
Hepatitis B and C
Primary sleep disorders
No Results Posted