Glutathione vs. Curcumin Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gulf War Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Curcumin

12 weeks 400mg orally twice a day

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

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.

Liposomal Glutathione

12 weeks 630mg orally twice a day

Group Type EXPERIMENTAL

Glutathione

Intervention Type DRUG

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.

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes