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

This study is currently recruiting participants.
Verified September 2017 by Giulio Maria Pasinetti, Icahn School of Medicine at Mount Sinai
Sponsor:
ClinicalTrials.gov Identifier:
NCT02915237
First Posted: September 26, 2016
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
United States Department of Defense
Department of Veterans Affairs, New Jersey
Information provided by (Responsible Party):
Giulio Maria Pasinetti, Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition Intervention Phase
Gulf War Illness Dietary Supplement: Concord grape juice Dietary Supplement: Placebo Beverage Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness

Further study details as provided by Giulio Maria Pasinetti, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Brief Symptom Inventory (BSI) [ Time Frame: 6 months ]
    to assess safety and tolerability to treatment. The test is a 53-item self report scale that uses the 5 point Likert scale.

  • Patient Health Questionnaire-15 (PHQ-15) [ Time Frame: 6 months ]
    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).

  • California Verbal Learning Test-Second Edition (CVLT-II) [ Time Frame: 6 months ]
    This test looks at cognitive functioning by assessing immediate recall and long-delayed recall.

  • The Chalder Fatigue Questionnaire [ Time Frame: 6 months ]
    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


Secondary Outcome Measures:
  • Wechsler Adult Intelligence Scale (WAIS-IV) [ Time Frame: 6 months ]
    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.

  • the Conner's Continuous Performance Test-3 (CPT-3) [ Time Frame: 6 months ]
    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.

  • the Trail Making Test (TMT) [ Time Frame: 6 months ]
    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).

  • Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Block Design Subtest [ Time Frame: 6 months ]
    A tool for testing adult intelligence level.

  • the Stroop Test [ Time Frame: 6 months ]
    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.

  • Halstead Category Test [ Time Frame: 6 months ]
    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.

  • Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: 6 months ]
    A tool to measure visuospatial learning and memory abilities.

  • Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span Subtest [ Time Frame: 6 months ]
    Digit Span measures short-term auditory memory and attention.


Estimated Enrollment: 60
Study Start Date: August 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose - Concord grape juice
Daily dietary supplementation with 4 oz. of a commercially available Concord grape juice.
Dietary Supplement: Concord grape juice
Daily dietary supplementation with a commercially available Concord grape juice.
Experimental: Moderate Dose - Concord grape juice
Daily dietary supplementation with 8 oz. of a commercially available Concord grape juice.
Dietary Supplement: Concord grape juice
Daily dietary supplementation with a commercially available Concord grape juice.
Experimental: High Dose - Concord grape juice
Daily dietary supplementation with 16 oz. of a commercially available Concord grape juice.
Dietary Supplement: Concord grape juice
Daily dietary supplementation with a commercially available Concord grape juice.
Placebo Comparator: Low dose - placebo beverage
Daily dietary supplementation with 4 oz. of a placebo beverage
Dietary Supplement: 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.
Placebo Comparator: Moderate Dose - placebo beverage
Daily dietary supplementation with 8 oz. of a placebo beverage
Dietary Supplement: 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.
Placebo Comparator: High Dose - placebo beverage
Daily dietary supplementation with 16 oz. of a placebo beverage
Dietary Supplement: 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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT02915237


Contacts
Contact: Giulio Maria Pasinetti, MD, PhD 212-241-7938 giulio.pasinetti@mssm.edu
Contact: Drew A Helmer, MD 800-248-8005 Drew.Helmer@va.gov

Locations
United States, New Jersey
VA- New Jersey Health Care System Recruiting
East Orange, New Jersey, United States, 07018
Contact: Drew A Helmer, MD, PhD    800-248-8005    Drew.Helmer@va.gov   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
United States Department of Defense
Department of Veterans Affairs, New Jersey
Investigators
Principal Investigator: Giulio Maria Pasinetti, MD, PhD Icahn School of Medicine at Mount Sinai
Study Director: Brett Chaney, MD United States Department of Defense
  More Information

Additional Information:
Publications:
Responsible Party: Giulio Maria Pasinetti, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02915237     History of Changes
Other Study ID Numbers: GCO 13-1398
First Submitted: September 23, 2016
First Posted: September 26, 2016
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Giulio Maria Pasinetti, Icahn School of Medicine at Mount Sinai:
Veterans
Gulf War Illness
Gulf War Veterans's Illness
Gulf War Veterans' Medically Unexplained Illnesses