Glutathione vs. Curcumin Clinical Trial

Gulf War Syndrome Clinical Trial

— Glutathione  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848417
• Other study ID #: 4987
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2016
• Est. completion date: August 2020

Study information

• Verified date: January 2020
• Source: South Florida Veterans Affairs Foundation for Research and Education
• Contact: Fanny V Collado, RN
• Phone: 305-575-7000
• Email: fanny.collado[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gulf War Syndrome
• Persian Gulf Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Miami VA Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
South Florida Veterans Affairs Foundation for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

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