Clinical trial NCT02915237: Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
Official title: Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gulf War Illness
Keywords: Veterans
Gulf War Illness
Gulf War Veterans's Illness
Gulf War Veterans' Medically Unexplained Illnesses
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Department of Veterans Affairs, New Jersey
First posted: 2016-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brief Symptom Inventory (BSI)
timeFrame: 6 months
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: 6 months
measure: California Verbal Learning Test-Second Edition (CVLT-II)
timeFrame: 6 months
measure: The Chalder Fatigue Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Wechsler Adult Intelligence Scale (WAIS-IV)
timeFrame: 6 months
measure: the Conner's Continuous Performance Test-3 (CPT-3)
timeFrame: 6 months
measure: the Trail Making Test (TMT)
timeFrame: 6 months
measure: Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Block Design Subtest
timeFrame: 6 months
measure: the Stroop Test
timeFrame: 6 months
measure: Halstead Category Test
timeFrame: 6 months
measure: Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: 6 months
measure: Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span Subtest
timeFrame: 6 months
Other outcomes:
Locations:
city: East Orange
country: United States
facility: VA- New Jersey Health Care System
state: New Jersey
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Giulio Maria Pasinetti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: United States Department of Defense
name: Brett Chaney, MD
role: STUDY_DIRECTOR
References:
citation: Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000 Nov 15;152(10):992-1002. doi: 10.1093/aje/152.10.992.
citation: Helmer DA, Van Doren WW, Litke DR, Tseng CL, Ho L, Osinubi O, Pasinetti GM. Safety, Tolerability and Efficacy of Dietary Supplementation with Concord Grape Juice in Gulf War Veterans with Gulf War Illness: A Phase I/IIA, Randomized, Double-Blind, Placebo-Controlled Trial. Int J Environ Res Public Health. 2020 May 19;17(10):3546. doi: 10.3390/ijerph17103546.