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Trial record 6 of 6 for:    Recruiting, Not yet recruiting, Available Studies | "Persian Gulf Syndrome"

Effects of Botanical Microglia Modulators in Gulf War Illness

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ClinicalTrials.gov Identifier: NCT02909686
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : August 15, 2017
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Jarred W. Younger, University of Alabama at Birmingham

Brief Summary:
The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic inflammation that cannot be measured with typical techniques. The investigators will be observing the effects of nine different botanical compounds (supplements) that are known to suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give the investigators information about what is wrong in people with GWI.

Condition or disease Intervention/treatment Phase
Gulf War Illness Dietary Supplement: Boswellia Serrata Dietary Supplement: Curcumin Dietary Supplement: Epimedium Dietary Supplement: Fisetin Dietary Supplement: Luteolin Dietary Supplement: Nettle Dietary Supplement: Pycnogenol Dietary Supplement: Reishi Mushroom Dietary Supplement: Resveratrol Dietary Supplement: Placebo Not Applicable

Detailed Description:

There is still a poor understanding of the pain, fatigue, and other symptoms that affect approximately 250,000 veterans. The precise mechanism of Gulf War Illness (GWI) is not understood, and there is no targeted treatment for the condition. A current model for GWI points to the central nervous system, immune cells, called microglia that may be hyperactive in patients with GWI. Discovering effective treatments for this disorder is a top priority of GWI research.

Given the investigator's preliminary data, it is suspected that GWI is a form of low-level neuroinflammation that involves hypersensitivity of receptors on microglia. In order to help test that hypothesis, the investigators will be administering supplements that have been shown in vitro or animal in vivo to suppress microglia function in a way that is anti-inflammatory and neuroprotective. If any of these agents suppress symptoms in GWI, it will give the investigators important information about the disease that may allow for creation of better diagnostic tools and treatments in future research studies. Observing the effects of the selected nine anti-inflammatory botanical compounds, in this clinical study, is a strong compliment to the ongoing mechanistic GWI research.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Botanical Microglia Modulators in Gulf War Illness
Study Start Date : July 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Boswellia Serrata
400-800mg in capsule form by mouth every day
Dietary Supplement: Boswellia Serrata
Other Name: Indian frankincense

Experimental: Curcumin
1000-2000mg in capsule form by mouth every day
Dietary Supplement: Curcumin
Other Names:
  • Curcumasorb
  • Turmeric extract
  • Meriva

Experimental: Epimedium
1000-2000mg in capsule form by mouth every day
Dietary Supplement: Epimedium
Other Names:
  • Barrenwort
  • Bishop's Hat
  • Fairy Wings
  • Horny Goat Weed
  • Yin Yang Huo

Experimental: Fisetin
200-800mg in capsule form by mouth every day
Dietary Supplement: Fisetin
Experimental: Luteolin
200-400mg in capsule form by mouth every day
Dietary Supplement: Luteolin
Experimental: Nettle
435-1305mg in capsule form by mouth every day
Dietary Supplement: Nettle
Other Names:
  • Common Nettle
  • urtica dioica
  • Stinging Nettle

Experimental: Pycnogenol
200-400mg in capsule form by mouth every day
Dietary Supplement: Pycnogenol
Other Names:
  • Maritime Pine Extract
  • Pine Bark Extract

Experimental: Reishi Mushroom
1600-3200mg in capsule form by mouth every day
Dietary Supplement: Reishi Mushroom
Experimental: Resveratrol
200-600mg in capsule form by mouth every day
Dietary Supplement: Resveratrol
Other Name: Red Wine Extract

Placebo Comparator: Placebo
in capsule form by mouth every day
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Change from baseline in overall Gulf War Illness disease severity [ Time Frame: Average disease severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported Gulf War Illness symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no symptoms; 100=severe symptoms).


Secondary Outcome Measures :
  1. Change from baseline in Pain Severity [ Time Frame: Average pain severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported pain severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no pain; 100=severe pain).

  2. Change from baseline in Fatigue Severity [ Time Frame: Average fatigue severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported fatigue severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not fatigued at all; 100=severely fatigued).

  3. Change from baseline in Cognitive Symptom Severity [ Time Frame: Average cognitive symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported cognitive symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not [able to think and remember] clearly at all; 100=[able to think and remember] very clearly).

  4. Change from baseline in Mood Symptom Severity [ Time Frame: Average mood severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported mood symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=not good [mood] at all; 100=extremely good [mood]).

  5. Change from baseline in Dermatological Symptom Severity [ Time Frame: Average dermatological symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported dermatological symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no skin problems at all; 100=severe skin problems).

  6. Change from baseline in Respiratory Symptom Severity [ Time Frame: Average respiratory symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported respiratory symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no breathing or respiratory problems at all; 100=severe breathing or respiratory problems).

  7. Change from baseline in Gastrointestinal Symptom Severity [ Time Frame: Average gastrointestinal symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. ]
    Self reported gastrointestinal symptom severity reported twice daily, in the morning and evening, for the duration of the study. Single item scored 0-100 (0=no bowel or GI problems at all; 100=severe bowel or GI problems).



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Ages Eligible for Study:   39 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male
  2. Age 39-65, inclusive
  3. Veterans who meet the Kansas inclusion criteria for GWI
  4. Present in Persian Gulf between 1990 and August 1991
  5. Patient completes daily report during 2 week baseline period (at least 80% completion rate)
  6. Able to receive a venous blood draw

Exclusion Criteria:

  1. Positive rheumatoid factor at screening
  2. Positive anti-nuclear antibody at screening
  3. C-reactive protein> 3mg/L at screening
  4. Erythrocyte Sedimentation Rate> 40mm/hr at screening
  5. Auto-immune disorder
  6. Diagnosed Rheumatologic Condition
  7. Major PTSD symptoms
  8. Hypotension (under 90/60 mm Hg) or history of cardiovascular disease
  9. Antihypertensive, anticoagulant medication, nitroglycerine, lithium medication use
  10. Diabetes with Hemoglobin A1C >9%
  11. History of anaphylaxis to study botanical compounds
  12. Current daily use of opioid medication
  13. Hospital Anxiety and Depression Scale, Depression subscale score of 16 or higher at baseline
  14. Current litigation of worker's compensation claim
  15. Blood or clotting disorder
  16. Acute infection (body temperature over 100 degrees F)
  17. Current daily use of confounding-anti-inflammatory medication as part of regular medication regimen
  18. Individuals that are not able to read & understand English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909686


Contacts
Contact: Emily K Donovan, BA 205-530-3796 gwi@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Emily K Donovan, BA    205-530-3796    gwi@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Congressionally Directed Medical Research Programs
Investigators
Principal Investigator: Jarred W Younger, PhD University of Alabama at Birmingham

Responsible Party: Jarred W. Younger, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02909686     History of Changes
Other Study ID Numbers: F150318011
CDMRP-GW130015 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs )
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by Jarred W. Younger, University of Alabama at Birmingham:
Gulf War Syndrome
Chronic Multisymptom Illnesses
Medically Unexplained Illnesses

Additional relevant MeSH terms:
Curcumin
Resveratrol
Turmeric extract
Pycnogenols
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antioxidants
Protective Agents
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents
Adjuvants, Immunologic
Immunologic Factors