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Glutathione vs. Curcumin Clinical Trial (Glutathione)

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ClinicalTrials.gov Identifier: NCT02848417
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nancy Klimas, South Florida Veterans Affairs Foundation for Research and Education

Tracking Information
First Submitted Date  ICMJE July 6, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date May 16, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Biomarker response to therapy using a VO2 exercise test [ Time Frame: 12 weeks ]
    Goal is that both will prove safe for use in GWI patients
  • Biomarker response to therapy using cytokine panel [ Time Frame: 12 weeks ]
    Goal is that both will prove safe for use in GWI patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02848417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutathione vs. Curcumin Clinical Trial
Official Title  ICMJE Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Gulf War Syndrome
Intervention  ICMJE
  • 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.
  • 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.
  • 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.

Study Arms  ICMJE
  • Experimental: Curcumin
    12 weeks 400mg orally twice a day
    Intervention: Drug: Curcumin
  • Experimental: Liposomal Glutathione
    12 weeks 630mg orally twice a day
    Intervention: Drug: Glutathione
  • 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

    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fanny V Collado, RN 305-575-7000 ext 6706 fanny.collado@va.gov
Contact: Elizabeth Balbin 305-275-5450 ebalbin@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848417
Other Study ID Numbers  ICMJE 4987
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nancy Klimas, South Florida Veterans Affairs Foundation for Research and Education
Study Sponsor  ICMJE South Florida Veterans Affairs Foundation for Research and Education
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elizabeth Balbin Nova University
PRS Account South Florida Veterans Affairs Foundation for Research and Education
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP