Gulf War IllnessPhase 1/2NCT02915237
Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
A Phase 1/2 study testing Concord grape juice in people with Gulf War Illness, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Concord grape juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 17 Jan 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA- New Jersey Health Care System
East Orange, New Jersey, 07018
About this study
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.
Read the 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.
- Conditions
- Gulf War Illness
- Being tested
- Concord grape juice, Placebo Beverage
- Keywords
- Veterans, Gulf War Illness, Gulf War Veterans's Illness, Gulf War Veterans' Medically Unexplained Illnesses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concord grape juiceDietary supplement
Daily dietary supplementation with a commercially available 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.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose - Concord grape juice | Experimental | Daily dietary supplementation with 4 oz. of a commercially available Concord grape juice. Receives: Dietary Supplement: Concord grape juice |
| Moderate Dose - Concord grape juice | Experimental | Daily dietary supplementation with 8 oz. of a commercially available Concord grape juice. Receives: Dietary Supplement: Concord grape juice |
| High Dose - Concord grape juice | Experimental | Daily dietary supplementation with 16 oz. of a commercially available Concord grape juice. Receives: Dietary Supplement: Concord grape juice |
| Low dose - placebo beverage | Placebo comparator | Daily dietary supplementation with 4 oz. of a placebo beverage Receives: Dietary Supplement: Placebo Beverage |
| Moderate Dose - placebo beverage | Placebo comparator | Daily dietary supplementation with 8 oz. of a placebo beverage Receives: Dietary Supplement: Placebo Beverage |
| High Dose - placebo beverage | Placebo comparator | Daily dietary supplementation with 16 oz. of a placebo beverage Receives: Dietary Supplement: Placebo Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 months
California Verbal Learning Test-Second Edition (CVLT-II)
This test looks at cognitive functioning by assessing immediate recall and long-delayed recall.
Measured: 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
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Block Design Subtest
A tool for testing adult intelligence level.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Brief Visuospatial Memory Test-Revised (BVMT-R)
A tool to measure visuospatial learning and memory abilities.
Measured: 6 months
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span Subtest
Digit Span measures short-term auditory memory and attention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Department of Veterans Affairs, New Jersey
- Responsible party
- Principal investigator, Giulio Maria Pasinetti, Icahn School of Medicine at Mount Sinai
- Investigators
- Giulio Maria Pasinetti, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiBrett Chaney, MD, Study director, United States Department of Defense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915237
- Sponsor's protocol ID
- GCO 13-1398
- Status last verified
- Jun 2020
- First submitted
- 23 Sep 2016
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11092441Helmer 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.
PubMed 32438639
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
- ClinicalTrials.gov ID
- NCT02915237
- Acronym / sponsor ID
- GCO 13-1398
- Conditions
- Gulf War Illness
- Keywords
- Veterans, Gulf War Illness, Gulf War Veterans's Illness, Gulf War Veterans' Medically Unexplained Illnesses
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- United States Department of Defense, Department of Veterans Affairs, New Jersey
- Study start
- Aug 2016
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low Dose - Concord grape juice | Experimental | Dietary Supplement: Concord grape juiceDaily dietary supplementation with 4 oz. of a commercially available Concord grape juice. |
| Moderate Dose - Concord grape juice | Experimental | Dietary Supplement: Concord grape juiceDaily dietary supplementation with 8 oz. of a commercially available Concord grape juice. |
| High Dose - Concord grape juice | Experimental | Dietary Supplement: Concord grape juiceDaily dietary supplementation with 16 oz. of a commercially available Concord grape juice. |
| Low dose - placebo beverage | Placebo comparator | Dietary Supplement: Placebo BeverageDaily dietary supplementation with 4 oz. of a placebo beverage |
| Moderate Dose - placebo beverage | Placebo comparator | Dietary Supplement: Placebo BeverageDaily dietary supplementation with 8 oz. of a placebo beverage |
| High Dose - placebo beverage | Placebo comparator | Dietary Supplement: Placebo BeverageDaily dietary supplementation with 16 oz. of a placebo beverage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concord grape juiceDaily dietary supplementation with a commercially available Concord grape juice. | Dietary supplement | High Dose - Concord grape juice, Low Dose - Concord grape juice, Moderate Dose - Concord grape juice |
| Placebo BeverageDaily 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. | Dietary supplement | High Dose - placebo beverage, Low dose - placebo beverage, Moderate Dose - placebo beverage |
Primary outcome
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
8 secondary outcomes
Wechsler Adult Intelligence Scale (WAIS-IV)
Time frame: 6 months
the Conner's Continuous Performance Test-3 (CPT-3)
Time frame: 6 months
the Trail Making Test (TMT)
Time frame: 6 months
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Block Design Subtest
Time frame: 6 months
the Stroop Test
Time frame: 6 months
Halstead Category Test
Time frame: 6 months
Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: 6 months
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span Subtest
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Background: PubMed 11092441Steele 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.
- Background: PubMed 32438639Helmer 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.
- Web link for research studies that are open to Gulf War Veteran research at the New Jersey War Related Illness and Injury Study CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gulf War Illness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulio Maria Pasinetti, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Brett Chaney, MD study director
United States Department of Defense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Concord grape juice in people with Gulf War Illness, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Symptom Inventory (BSI) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915237, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.