Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Gulf War Illness
In brief
Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for GWI currently available, there is an urgent need to develop novel interventions to alleviate major GWI clinical complications. Recent evidence highlights the potential value of flavonoids, a subclass of organic chemical called polyphenols abundantly found in some plants and common dietary preparations, in helping relieve clinical complications in Veterans with GWI. The overall goal is to test whether daily consumption of commercially available Concord grape juice, which is very Flavonoid-rich, is effective for treating cognitive deficits and chronic fatigue in Veterans with GWI.
Key facts
- Study ID
- NCT02915237
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 36
- Starts
- 2016-08-01
- Expected to finish
- 2019-01-17
- Last updated by the study team
- 2020-06-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Gulf War Veterans deployed to the Persian Gulf theatre between August 1990 and August 1991. GWI will be defined according to the Kansas Case Definition. The Kansas Case Definition identifies 6 symptom domains and requires endorsement of moderately severe and/or multiple symptoms in at least 3 of those domains. To meet the case definition, the Veterans must also indicate that each symptom first became problematic during or within one year of the Gulf War.
You may not qualify if…
- Individuals not meeting the inclusion criteria for Gulf War deployment and definition of GWI, or with conditions that might interfere with their ability to report their symptoms (e.g., drug use) are excluded.
- Additional exclusion criteria are current medical conditions that may explain the symptoms (diabetes, heart disease, among others) or significant current (in the past six months) unstable (requiring significant medication adjustments or hospitalization) psychiatric conditions, including suicidal or homicidal ideation, schizophrenia or bipolar disorder according to subject responses to the interview and review by the principal investigator.
- Subjects who usually consume abnormally high contents of dietary polyphenol based on a self-reported diet diary will be excluded.
Where it is running
- VA- New Jersey Health Care System — East Orange, New Jersey, United States
Full record on ClinicalTrials.gov
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