Gulf War IllnessPhase 2MINERNCT03665740
Multimodal Investigation of the Neuroprotective Effects of Resveratrol (MINER)
A Phase 2 study testing Resveratrol in people with Gulf War Illness, run by VISN 17 Center of Excellence at 1 site in United States.
Trial summary
Since their return from military service in the 1990-1991 Gulf War, many Veterans have been affected by debilitating symptoms that are not easily explained. A leading hypothesis states that the combination of exposure to toxic chemicals and environmental stressors are responsible for a cluster of debilitating symptoms… Read more about this study
- Who is it for?
- Ages 44 to 68 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Aug 2022
- Phase
- Phase 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 44 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Served on active military duty and deployed to the Persian Gulf region August 1990 - July 1991;
- English speaking and able to understand the consent form and study questionnaires;
- Willing and able to be randomized to treatment and to commit to a 26-week study;
- Men and women between the ages of 44 to 68 (the number of 1990-1991 Gulf War Veterans who are older than 68 dramatically decreases because many of those with GWI have died prematurely);
- Meet the Kansas case definition for the diagnosis of GWI as well as the more inclusive CDC definition
- Stabilization on any psychiatric medication (≥3 months on selective serotonin reuptake inhibitor or monoamine oxidase inhibitor, ≥1 month on anxiolytic or beta-blockers);
- Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use reliable method of birth control (for example, oral contraceptives or Norplant; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices; partner with vasectomy; or abstinence) during the study. Note that this inclusion criterion applies only to females of childbearing potential. Females of childbearing potential are defined as women not surgically sterilized and between menarche and 2 years post-menopause.
Who cannot join
- Unstable or poorly controlled diabetes type II (HbA1C >9.0);
- Cancer;
- Lifetime diagnosis of schizophrenia or bipolar disorder or a history of psychiatric hospitalization for, or current diagnosis (i.e., the past 6 months) of substance dependence;
- Major depressive disorder or posttraumatic stress disorder requiring hospitalization;
- Significant CNS disease including TIAs or stroke, dementia, syncopal episodes, severe head trauma, multiple sclerosis;
- Serious or advanced heart disease or clinically relevant abnormal electrocardiogram (ECG) or postural hypotension;
Show all 23Show fewer
- Untreated sleep apnea or body mass index (BMI) placing patients at risk for undiagnosed sleep apnea (BMI≥35 kg/m2);
- Subjects with renal insufficiency or chronic renal disease defined by national Kidney Foundation Disease Outcome Quality Initiative criteria (2000) with a GFR less than or equal to 90 mL/min/1.73m2. Laboratory monitoring of CR and Bun and eGFR will be obtained at baseline and prior to each titration and at study end or early termination. If Cr and Bun increase above upper limit of normal and eGFR drops to <45 or more than 35% the study drug will be discontinued and a nephrology consult will be ordered;
- Liver enzymes >3 times normal on 3 consecutive laboratory tests; evidence of significant hepatocellular injury as evidenced by elevated serum levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN); total or indirect bilirubin greater than 1.2 x ULN; alkaline phosphatase greater than 1.5 x ULN; prothrombin time (PT) as INR greater than 2.4 x ULN; or albumin less than 1 times the lower limit of normal (LLN) at baseline. Resveratrol is only anticipated to affect LFTs indirectly, by slowing statin metabolism. Persistent significant elevation of amino transferases are defined as >3x normal of normal upper limit on 2 consecutive measurements. Under the conditions of high dose statin therapy, it is typically addressed by temporarily stopping statin administration, then slowly titrating the dose back up under careful observation. Failure to reduce aminotransferase levels after the temporary cessation of statins (and a third LFT measurement is taken) would necessitate cessation of resveratrol treatment.
- Use of cytochrome P450 3A4 substrates with high risk of toxicity (e.g., terfenadine, cisapride, astemizole, disopyramide, amiodarone, dronedarone, colchicine, cyclosporine, quinidine, pimozide, cisapride, amlodipine, felodipine, nicardipine, nifedipine, nisoldipine, nitrendipin, nimodipine and verapamil);
- Use of blood thinners (e.g., Coumadin);
- Use of resveratrol-containing supplements.
- Participation in the scanning portion of the study is not required to participate in the clinical trial. Subjects who are interested in the scanning study will be asked to sign a second consent and will be screened for MRI-specific exclusion criteria. The additional exclusion criteria for participating in the MRI portion are listed below.
- General medical conditions that would prevent the participant from completing MRI scanning (active seizure disorder, dementia, active back or muscle spasms);
- Positive MRI safety screen for metal or history of penetrating head or eye wound without subsequent radiological evidence that the wound is metal-free;
- Participants that are (were) welders or that have had metal surgically removed from their eyes without radiological evidence that the wound is metal-free;
- MRI quality problems (tremors, significant claustrophobia);
- Shrapnel or other metal embedded in the body;
- Implanted orthopedic devices (e.g., metal rods, plates or screws but excluding nonferrous material);
- Implanted metal devices or prosthetics, or mechanical implants (e.g., pacemakers, electrical implants, cochlear implants);
- Implanted contraceptive devices (excluding those made of nonferrous material);
- Outside devices made of metal (e.g., neck braces, surgical staples, or artificial limbs), or non-removable dentures, braces or other metal orthodontics;
- Tattoos not done professionally or non-removable body piercings.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VISN 17 Center of Excellence for Research on Returning War Veterans
Waco, Texas, 76711
Tabitha Alverio, M.A., 254-297-3259, Tabitha.Alverio@va.gov
Laura Constable, Ph.D., 254.297.3954, Laura.Constable@va.gov
About this study
Official title: A Pilot RCT on the Effect of Resveratrol on Mood, Memory Deficits, Hippocampal Inflammation and Neurogenesis in Veterans With Gulf War Illness
Since their return from military service in the 1990-1991 Gulf War, many Veterans have been affected by debilitating symptoms that are not easily explained. A leading hypothesis states that the combination of exposure to toxic chemicals and environmental stressors are responsible for a cluster of debilitating symptoms known as Gulf War Illness (GWI). Research has found that over-the-counter antioxidant supplements such as resveratrol may reverse the damage that causes these debilitating symptoms. Resveratrol is a nutrient found abundantly in the skin of red grapes that is known to have robust antioxidant and anti-inflammatory properties. The investigators predict that resveratrol treatment will improve memory issues, difficulties with thinking and mood problems in Veterans with GWI and that resveratrol will do so with minimal risk.
Read the detailed description
A randomized controlled trial is proposed that will employ well-validated instruments and state-of-the-art techniques to assess improvements in cognitive functioning, functional status, mood, hippocampal neurogenesis and functional connectivity as well as anti-inflammatory and antioxidant effects of treatment with resveratrol. Design: The proposed study will be an intent-to-treat outpatient, randomized, double-blind, clinical trial of 93 Veterans who meet the Centers for Disease Control and Prevention and Kansas case definitions for GWI.
The study involves a comparison of resveratrol at a dose of 2000 mg and placebo. All doses will be administered orally once or twice daily. Doses of resveratrol at 500 mg will begin with a dose titration period. In order to reach a maximum dose of 2000 mg for the resveratrol, titration will begin at 500 mg for 6 weeks, then increased to 1000 mg for 6 weeks and increased to 1500 mg for 6 weeks and increased to 2000 mg for the remaining 6 weeks on treatment. Morning dosing will be taken with or before breakfast. Evening dosing will be taken with or before dinner.
- Conditions
- Gulf War Illness
- Being tested
- Resveratrol
- Keywords
- Gulf War Illness, Chronic Multisymptom Illness, Antioxidants, Resveratrol, Gulf War Syndrome
- Medical subject headings
- Persian Gulf Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
resveratrol is an OTC supplement
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Doses of resveratrol at 500 mg will begin with a dose titration period. In order to reach a maximum dose of 2000 mg for the resveratrol, titration will begin at 500 mg for 6 weeks, then increased to 1000 mg for 6 weeks and increased to 1500 mg for 6 weeks and increased to 2000 mg for the remaining 6 weeks on treatment. Receives: Drug: Resveratrol |
| Placebo | Placebo comparator | Doses of placebo at 500 mg will begin with a dose titration period. In order to reach a maximum dose of 2000 mg for the placebo, titration will begin at 500 mg for 6 weeks, then increased to 1000 mg for 6 weeks and increased to 1500 mg for 6 weeks and increased to 2000 mg for the remaining 6 weeks on treatment Receives: Drug: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Cognitive Function
CVLT-II: measure of cognitive functioning and memory
Measured: Baseline & Post (week 26)
Change from baseline in Mood
Beck Depression Inventory II
Measured: Baseline, Mid (week 13) and Post (week 26)
Change from baseline in Daily Functioning
WHODAS 2.0: measure of disability and global health
Measured: Baseline and Post (week 26)
Secondary outcomes (2)
Change from baseline in Structural MRI Scans
Structural MRI scanning of hippocampus
Measured: Baseline & Post (Week 26)
Change from baseline in Diffusion Tensor Imaging
A diffusion tensor imaging scan of hippocampus
Measured: Baseline & Post (Week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Aug 2018
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double-blind Placebo controlled, intent-to-treat
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VISN 17 Center of Excellence
- Sponsor type
- US federal agency
- Collaborators
- Texas A&M University, Baylor University, KR Love Quantitative Consulting and Collaboration
- Responsible party
- Principal investigator, Dena Davidson, VISN 17 Center of Excellence
- Investigators
- Dena Davidson, Ph.D., Principal investigator, VISN 17 Center of Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665740
- Sponsor's protocol ID
- GW160050
- Acronym
- MINER
- Status last verified
- Sep 2018
- First submitted
- 8 Aug 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot RCT on the Effect of Resveratrol on Mood, Memory Deficits, Hippocampal Inflammation and Neurogenesis in Veterans With Gulf War Illness
- ClinicalTrials.gov ID
- NCT03665740
- Acronym / sponsor ID
- MINER / GW160050
- Conditions
- Gulf War Illness
- Keywords
- Gulf War Illness, Chronic Multisymptom Illness, Antioxidants, Resveratrol, Gulf War Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- VISN 17 Center of ExcellenceUS federal agency
- Collaborators
- Texas A&M University, Baylor University, KR Love Quantitative Consulting and Collaboration
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 11 Sep 2018 (actual)
- 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.
Since their return from military service in the 1990-1991 Gulf War, many Veterans have been affected by debilitating symptoms that are not easily explained. A leading hypothesis states that the combination of exposure to toxic chemicals and environmental stressors are responsible for a cluster of debilitating symptoms known as Gulf War Illness (GWI). Research has found that over-the-counter antioxidant supplements such as resveratrol may reverse the damage that causes these debilitating symptoms. Resveratrol is a nutrient found abundantly in the skin of red grapes that is known to have robust antioxidant and anti-inflammatory properties. The investigators predict that resveratrol treatment will improve memory issues, difficulties with thinking and mood problems in Veterans with GWI and that resveratrol will do so with minimal risk.
Detailed description
A randomized controlled trial is proposed that will employ well-validated instruments and state-of-the-art techniques to assess improvements in cognitive functioning, functional status, mood, hippocampal neurogenesis and functional connectivity as well as anti-inflammatory and antioxidant effects of treatment with resveratrol. Design: The proposed study will be an intent-to-treat outpatient, randomized, double-blind, clinical trial of 93 Veterans who meet the Centers for Disease Control and Prevention and Kansas case definitions for GWI.
The study involves a comparison of resveratrol at a dose of 2000 mg and placebo. All doses will be administered orally once or twice daily. Doses of resveratrol at 500 mg will begin with a dose titration period. In order to reach a maximum dose of 2000 mg for the resveratrol, titration will begin at 500 mg for 6 weeks, then increased to 1000 mg for 6 weeks and increased to 1500 mg for 6 weeks and increased to 2000 mg for the remaining 6 weeks on treatment. Morning dosing will be taken with or before breakfast. Evening dosing will be taken with or before dinner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double-blind Placebo controlled, intent-to-treat
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Drug: ResveratrolDoses of resveratrol at 500 mg will begin with a dose titration period. In order to reach a maximum dose of 2000 mg for the resveratrol, titration will begin at 500 mg for 6 weeks, then increased to 1000 mg for 6 weeks and increased to 1500 mg for 6 weeks and increased to 2000 mg for the remaining 6 weeks on treatment. |
| Placebo | Placebo comparator | Drug: ResveratrolDoses of placebo at 500 mg will begin with a dose titration period. In order to reach a maximum dose of 2000 mg for the placebo, titration will begin at 500 mg for 6 weeks, then increased to 1000 mg for 6 weeks and increased to 1500 mg for 6 weeks and increased to 2000 mg for the remaining 6 weeks on treatment |
Who may qualify
- Ages
- 44 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Served on active military duty and deployed to the Persian Gulf region August 1990 - July 1991;
- English speaking and able to understand the consent form and study questionnaires;
- Willing and able to be randomized to treatment and to commit to a 26-week study;
- Men and women between the ages of 44 to 68 (the number of 1990-1991 Gulf War Veterans who are older than 68 dramatically decreases because many of those with GWI have died prematurely);
- Meet the Kansas case definition for the diagnosis of GWI as well as the more inclusive CDC definition
Key exclusion criteria (23 listed)
- Unstable or poorly controlled diabetes type II (HbA1C >9.0);
- Cancer;
- Lifetime diagnosis of schizophrenia or bipolar disorder or a history of psychiatric hospitalization for, or current diagnosis (i.e., the past 6 months) of substance dependence;
- Major depressive disorder or posttraumatic stress disorder requiring hospitalization;
- Significant CNS disease including TIAs or stroke, dementia, syncopal episodes, severe head trauma, multiple sclerosis;
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 |
|---|---|---|
| Resveratrolresveratrol is an OTC supplement | Drug | Placebo, Resveratrol |
Primary outcome
Change from baseline in Cognitive Function
Time frame: Baseline & Post (week 26)
CVLT-II: measure of cognitive functioning and memory
Change from baseline in Mood
Time frame: Baseline, Mid (week 13) and Post (week 26)
Beck Depression Inventory II
Change from baseline in Daily Functioning
Time frame: Baseline and Post (week 26)
WHODAS 2.0: measure of disability and global health
2 secondary outcomes
Change from baseline in Structural MRI Scans
Time frame: Baseline & Post (Week 26)
Change from baseline in Diffusion Tensor Imaging
Time frame: Baseline & Post (Week 26)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Website for the VISN 17 Center of Excellence for Research on Returning War VeteransLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gulf War Illness
RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Gulf War Illness
RecruitingPhase 2
Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
Recruiting
Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
Recruiting
Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
Gulf War Illness, Headache
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.
Dena Davidson, Ph.D. principal investigator
VISN 17 Center of Excellence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol in people with Gulf War Illness, run by VISN 17 Center of Excellence 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 7 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 11 Sep 2018. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tabitha Alverio, M.A. (254.297.3259, Tabitha.Alverio@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Cognitive Function (time frame: Baseline & Post (week 26)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.