Glutathione vs. Curcumin Clinical Trial (Glutathione)

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

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.

Study Overview

• Status: Unknown
• Conditions: Gulf War Syndrome
• Intervention / Treatment: Drug: Curcumin; Drug: Glutathione; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • Recruiting
      • Miami VA Center
      • Contact: Nancy Klimas, MD; Phone Number: 4800 305-575-7000; Email: Nacy.klimas@va.gov
      • Contact: Fanny Collado, RN; Phone Number: 6706 305-575-7000; Email: fanny.collado@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin; 12 weeks 400mg orally twice a day	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.
Experimental: Liposomal Glutathione; 12 weeks 630mg orally twice a day	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.
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	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: South Florida Veterans Affairs Foundation for Research and Education
• Investigators: Study Director: Elizabeth Balbin, Nova University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Occupational Diseases; Persian Gulf Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 4987