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

Gulf War Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915237
• Other study ID #: GCO 13-1398
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2016
• Est. completion date: January 17, 2019

Study information

• Verified date: June 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gulf War Illness

Intervention

Dietary Supplement:
• Concord grape juice
Daily dietary supplementation with a commercially available Concord grape juice.
• Placebo Beverage
Daily dietary supplementation with a placebo beverage consisting of water, sugar, artificial flavoring and color that is formulated to look and taste like grape juice and have the same carbohydrate composition and energy load.

Locations

Country	Name	City	State
United States	VA- New Jersey Health Care System	East Orange	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Department of Veterans Affairs, New Jersey, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

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). pii: E3546. doi: 10.3390/ijerph17103546. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Symptom Inventory (BSI)	to assess safety and tolerability to treatment. The test is a 53-item self report scale that uses the 5 point Likert scale.	6 months
Primary	Patient Health Questionnaire-15 (PHQ-15)	to assess safety and tolerability to treatment. The Patient Health Questionnaire 15 (PHQ 15) is a validated measure of somatic symptom severity in functional somatic syndromes (FSS). Scale ranges from 0-30 (mild to severe).	6 months
Primary	California Verbal Learning Test-Second Edition (CVLT-II)	This test looks at cognitive functioning by assessing immediate recall and long-delayed recall.	6 months
Primary	The Chalder Fatigue Questionnaire	The Chalder Fatigue Questionnaire assess chronic fatigue. Each of the 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology	6 months
Secondary	Wechsler Adult Intelligence Scale (WAIS-IV)	The Digit Span subtest is a widely used measure of auditory attention that is well-normed and sensitive. The subtest has three parts - digits forward, backward, and sequencing.	6 months
Secondary	the Conner's Continuous Performance Test-3 (CPT-3)	The CPT-3 assist in clinical assessment of attention problems. The patient is instructed to press the space bar (or mouse button) immediately following the presentation of specific letters on screen. The test normally takes 14 minutes to administer.	6 months
Secondary	the Trail Making Test (TMT)	The TMT consists of two forms, parts A and B. This measure taps both simple graphomotor speed (Part A) and adds in a rapid set-shifting paradigm that taps executive functioning (Part B).	6 months
Secondary	Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Block Design Subtest	A tool for testing adult intelligence level.	6 months
Secondary	the Stroop Test	The Stroop Color and Word Test consists of a Word Page with color words printed in black ink, a Color Page with 'Xs' printed in color, and a color-Word Page with words from the first page printed in colors from the second page (the color and the word do not match). The respondent goes down each sheet reading words or naming the ink colors as quickly as possible within a time limit. The test yields three scores based on the number of items completed on each of the three stimulus sheets. An Interference score, which is useful in determining the individual's cognitive flexibility, creativity, and reaction to cognitive pressures also can be calculated.	6 months
Secondary	Halstead Category Test	This test takes approximately 30 minutes and consists of 120 items, presented visually. The participant must decipher the underlying principle of the stimulus set. Total number of errors will be used.	6 months
Secondary	Brief Visuospatial Memory Test-Revised (BVMT-R)	A tool to measure visuospatial learning and memory abilities.	6 months
Secondary	Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span Subtest	Digit Span measures short-term auditory memory and attention.	6 months

External Links

•   Web link for research studies that are open to Gulf War Veteran research at the New Jersey War Related Illness and Injury Study Center