NCT02915237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

September 23, 2016

Last Update Submit

June 25, 2020

Conditions

Gulf War Illness

Keywords

VeteransGulf War IllnessGulf War Veterans's IllnessGulf War Veterans' Medically Unexplained Illnesses

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • California Verbal Learning Test-Second Edition (CVLT-II)

    This test looks at cognitive functioning by assessing immediate recall and long-delayed recall.

    6 months

  • 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 Outcomes (8)

  • Wechsler Adult Intelligence Scale (WAIS-IV)

    6 months

  • the Conner's Continuous Performance Test-3 (CPT-3)

    6 months

  • the Trail Making Test (TMT)

    6 months

  • Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Block Design Subtest

    6 months

  • the Stroop Test

    6 months

  • +3 more secondary outcomes

Study Arms (6)

Low Dose - Concord grape juice

EXPERIMENTAL

Daily dietary supplementation with 4 oz. of a commercially available Concord grape juice.

Dietary Supplement: Concord grape juice

Moderate Dose - Concord grape juice

EXPERIMENTAL

Daily dietary supplementation with 8 oz. of a commercially available Concord grape juice.

Dietary Supplement: Concord grape juice

High Dose - Concord grape juice

EXPERIMENTAL

Daily dietary supplementation with 16 oz. of a commercially available Concord grape juice.

Dietary Supplement: Concord grape juice

Low dose - placebo beverage

PLACEBO COMPARATOR

Daily dietary supplementation with 4 oz. of a placebo beverage

Dietary Supplement: Placebo Beverage

Moderate Dose - placebo beverage

PLACEBO COMPARATOR

Daily dietary supplementation with 8 oz. of a placebo beverage

Dietary Supplement: Placebo Beverage

High Dose - placebo beverage

PLACEBO COMPARATOR

Daily dietary supplementation with 16 oz. of a placebo beverage

Dietary Supplement: Placebo Beverage

Interventions

Concord grape juiceDIETARY_SUPPLEMENT

Daily dietary supplementation with a commercially available Concord grape juice.

High Dose - Concord grape juiceLow Dose - Concord grape juiceModerate Dose - Concord grape juice
Placebo BeverageDIETARY_SUPPLEMENT

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.

High Dose - placebo beverageLow dose - placebo beverageModerate Dose - placebo beverage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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:

  • Subjects who usually consume abnormally high contents of dietary polyphenol based on a self-reported diet diary will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA- New Jersey Health Care System

East Orange, New Jersey, 07018, United States

Location

Related Publications (2)

  • 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.

    PMID: 11092441BACKGROUND

  • 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.

    PMID: 32438639BACKGROUND

Related Links

Study Officials

  • Giulio Maria Pasinetti, MD, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Brett Chaney, MD

    United States Department of Defense

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 26, 2016

Study Start

August 1, 2016

Primary Completion

January 17, 2019

Study Completion

January 17, 2019

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)