Glutathione vs. Curcumin Clinical Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 5/18/2018 |
| Start Date: | April 2016 |
| End Date: | January 2019 |
| Contact: | Fanny V Collado, RN |
| Email: | fanny.collado@va.gov |
| Phone: | 305-575-7000 |
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.
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.
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.
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.
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
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