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
1 other identifier
interventional
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJanuary 29, 2020
January 1, 2020
3.3 years
July 6, 2016
January 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Curcumin
EXPERIMENTAL12 weeks 400mg orally twice a day
Liposomal Glutathione
EXPERIMENTAL12 weeks 630mg orally twice a day
Placebo Liquid or Capsules
EXPERIMENTALPlacebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- Veterans with Gulf War Illness
- to 70 years old
- Good health by medical history prior to 1990
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miami VA Center
Miami, Florida, 33125, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elizabeth Balbin
Nova University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 28, 2016
Study Start
April 1, 2016
Primary Completion
August 1, 2019
Study Completion
August 1, 2020
Last Updated
January 29, 2020
Record last verified: 2020-01