Glutathione vs. Curcumin Clinical Trial

South Florida Veterans Affairs Foundation for Research and Education

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Gulf War Syndrome

Treatments: Other: Placebo; Drug: Glutathione; Drug: Curcumin

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02848417

4987

Details and patient eligibility

About

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 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Curcumin

Experimental group

Description:

12 weeks 400mg orally twice a day

Treatment:

Drug: Curcumin

Liposomal Glutathione

Experimental group

Description:

12 weeks 630mg orally twice a day

Treatment:

Drug: Glutathione

Placebo Liquid or Capsules

Experimental group

Description:

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

Treatment:

Other: Placebo