Development of a Polyphenol-rich Dietary Preparation for Treating Veterans

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits. Clinical complications of GWI typically persist over long-term, cause significant pain and suffering, and interfere with the ability of affected Veterans to successfully integrate back into civilian society. There is no treatment for GWI and there is an urgent need to develop novel interventions either to resolve underlying GWI mechanisms, or to alleviate major GWI clinical complications.

Recent Evidence highlights the potential value of flavonoids, a subclass of organic chemical called polyphenols that are abundantly found in some plants and common dietary preparations may help alleviate chronic fatigue and preserve cognitive functions. Based on this, the overall goal is to test whether the potential efficacy of dietary supplementation with a commercially available flavonoid-rich product, alleviates clinical complications in Veterans with GWI. In particular, the researchers propose a randomized, double-blind, placebo-controlled Phase I/IIA study to test the feasibility and potential efficacy of Concord grape juice dietary supplementation to treat cognitive deficits and chronic fatigue in Veterans with GWI. ;

Study Design

Related Conditions & MeSH terms

Gulf War Illness

Clinical Trial Details

NCT number	NCT02915237
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 2016
Completion date	January 17, 2019

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT02011542` - Probiotic (VSL #3) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT03078530` - Probiotic (Visbiome) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT04058275` - "Immunomodulation in GWI (Phlebotomy)"
Recruiting	`NCT04255498` - Understanding GWI: Integrative Modeling	Phase 1
Completed	`NCT02782780` - Cognitive Behavioral Therapy for Insomnia for Gulf War Illness	N/A
Recruiting	`NCT02983734` - D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)	Phase 2
Recruiting	`NCT05972291` - Mechanisms of Gulf War Illness	N/A
Recruiting	`NCT04182659` - Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms	N/A
Recruiting	`NCT04046536` - rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)	N/A
Recruiting	`NCT05377242` - Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI	N/A
Recruiting	`NCT05675878` - Confirmation of Diet as a Treatment for Gulf War Illness	Phase 3
Recruiting	`NCT05736146` - Validating Gulf War Illness Blood Biomarkers
Not yet recruiting	`NCT05820893` - Resistant Potato Starch to Alleviate GWI	Phase 2
Terminated	`NCT01846182` - Research Examining Gulf War Illness in Our Nations Service Members	Phase 2
Active, not recruiting	`NCT05252949` - OEA for Targeting Lipid Metabolism in GWI	N/A
Completed	`NCT02378025` - Treating Chronic Pain in Gulf War Illness	N/A
Completed	`NCT02865460` - Coenzyme Q10 Phase III Trial in Gulf War Illness	Phase 3
Completed	`NCT02909686` - Effects of Botanical Microglia Modulators in Gulf War Illness	N/A
Completed	`NCT01291758` - Exercise in Gulf War Illness (GWI)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms