Gulf War SyndromePhase 1/2GlutathioneNCT02848417
Glutathione vs. Curcumin Clinical Trial
A Phase 1/2 study testing Curcumin and Glutathione in people with Gulf War Syndrome, run by South Florida Veterans Affairs Foundation for Research and Education at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gulf War Syndrome
- What is being tested?
- Curcumin and Glutathione
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major depression with psychotic or melancholic features
- Schizophrenia
- Bipolar disorder
- Delusional disorders
- Dementias of any type
- History or current alcohol abuse
Show all 16Show fewer
- History or current drug abuse
- Current tobacco use
- Organ failure
- Defined rheumatologic
- Inflammatory disorders
- HIV
- Hepatitis B and C
- Primary sleep disorders
- Steroids
- Immunosuppressives
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miami VA Center
Miami, Florida, 33125
Nancy Klimas, MD, 305-575-7000 ext. 4800, Nacy.klimas@va.gov
Fanny Collado, RN, 305-575-7000 ext. 6706, fanny.collado@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Gulf War Syndrome
- Being tested
- Curcumin, Glutathione, Placebo
- Medical subject headings
- Persian Gulf Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
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.
GlutathioneDrug
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | 12 weeks 400mg orally twice a day Receives: Drug: Curcumin |
| Liposomal Glutathione | Experimental | 12 weeks 630mg orally twice a day Receives: Drug: Glutathione |
| Placebo Liquid or Capsules | Experimental | Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml
Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker response to therapy using a VO2 exercise test
Goal is that both will prove safe for use in GWI patients
Measured: 12 weeks
Biomarker response to therapy using cytokine panel
Goal is that both will prove safe for use in GWI patients
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2019
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and Education
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Nancy Klimas, South Florida Veterans Affairs Foundation for Research and Education
- Investigators
- Elizabeth Balbin, Study director, Nova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848417
- Sponsor's protocol ID
- 4987
- Acronym
- Glutathione
- Status last verified
- Jan 2020
- First submitted
- 6 Jul 2016
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin
- ClinicalTrials.gov ID
- NCT02848417
- Acronym / sponsor ID
- Glutathione / 4987
- Conditions
- Gulf War Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and EducationUS federal agency
- Study start
- Apr 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2020 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: Curcumin12 weeks 400mg orally twice a day |
| Liposomal Glutathione | Experimental | Drug: Glutathione12 weeks 630mg orally twice a day |
| Placebo Liquid or Capsules | Experimental | Other: PlaceboPlacebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Major depression with psychotic or melancholic features
- Schizophrenia
- Bipolar disorder
- Delusional disorders
- Dementias of any type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminPerform 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 | Curcumin |
| GlutathionePerform 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. | Drug | Liposomal Glutathione |
| PlaceboPlacebo 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. | Other | Placebo Liquid or Capsules |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
Related trials for Gulf War Syndrome
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Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Balbin study director
Nova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Curcumin and Glutathione in people with Gulf War Syndrome, run by South Florida Veterans Affairs Foundation for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanny V Collado, RN (305-575-7000 ext. 6706, fanny.collado@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker response to therapy using a VO2 exercise test (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.