Diet for Gulf War Syndrome
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: American University
Must not be taking: Glutamatergic, GABAergic
Disqualifiers: Substance use disorder, Seizure, Asthma, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This clinical trial aims to confirm previous findings from a smaller study which demonstrated significant improvements in all symptoms among veterans with Gulf War Illness after one month on the dietary intervention. The main objectives of this study are: 1) to confirm previous findings of treatment response to the diet in a larger and more diverse group; 2) to examine how changes in the nervous system may be the reason for improvement; and 3) to identify markers which change in the blood after one month on the diet. Participants will have baseline measures collected and then will be randomized into the intervention or wait-listed control group, which they will follow for one month before being reassessed.
Will I have to stop taking my current medications?
Participants must keep their current medications and supplements stable throughout the study. However, if you are taking medication that affects certain brain chemicals, you may need to work with your doctor to stop those before joining the trial.
What data supports the effectiveness of the treatment Dietary Intervention, Nutritional Counseling, Dietary Therapy for Gulf War Syndrome?
Research shows that dietary interventions, like reducing salt and fat intake, can effectively manage conditions such as high blood pressure. Additionally, certain dietary components, like omega-3 fatty acids and vitamins, have been found to positively influence the immune system, which may be beneficial for various health conditions.12345
Is the dietary intervention for Gulf War Syndrome safe for humans?
Dietary interventions, like those involving omega-3 fatty acids, are generally considered safe for humans. Omega-3s have not been shown to increase bleeding risk, and purification processes reduce the risk of environmental toxins. However, it's important to be cautious with dietary supplements, as some can pose risks, and it's best to consult with a healthcare provider.678910
How does the dietary intervention for Gulf War Syndrome differ from other treatments?
The dietary intervention for Gulf War Syndrome is unique because it focuses on changing eating habits through nutritional counseling and dietary therapy, which is different from standard medical treatments that might involve medication. This approach aims to improve health by modifying diet, similar to how dietary changes can help manage conditions like hypertension (high blood pressure) and diabetes.411121314
Eligibility Criteria
This trial is for men and women up to 75 years old who served in the 1990-1991 Persian Gulf War and meet specific criteria for Gulf War Illness. They must have been on a stable medication regimen for at least one month and be willing to maintain it, as well as their supplement intake, without changes during the study.Inclusion Criteria
Served in the 1990-1991 Persian Gulf War
I am 75 years old or younger.
My medications have been the same for over a month and I can keep them stable during the study.
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Exclusion Criteria
Unwilling to stop using alcohol, tobacco (including vaping) and/or marijuana; or unwilling to change diet
Recent substance use disorder (past year)
I am on medication that affects brain signaling but can stop if needed.
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline measures are collected before randomization into intervention or control group
1 week
1 visit (in-person)
Dietary Intervention
Participants undergo a 2-hour training on the diet and follow it for 4 weeks
4 weeks
1 visit (virtual) for training
Control Period
Waitlisted control group follows usual diet for 1 month before reassessment
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Dietary Intervention (Other)
Trial OverviewThe trial is testing a dietary intervention that previously showed symptom improvement in veterans with Gulf War Illness. Participants will be split into two groups: one following the diet and another wait-listed control group. The study aims to confirm earlier results, understand nervous system changes due to the diet, and identify blood markers after one month.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Dietary Intervention GroupExperimental Treatment1 Intervention
Subjects will undergo a 2-hour in-depth training via Zoom on how to follow the diet and will receive a binder with helpful information. They will be give the weekend to prepare and then will start the diet the following Monday, and will continue following it for 4 weeks before being reassessed in the lab.
Group II: Waitlisted Control GroupActive Control1 Intervention
The waitlisted control group will follow their usual diet for one month and then will be reassessed (as a comparator group) before being trained on the dietary intervention which they will then follow for the next month.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston UniversityBoston, MA
Nova Southeastern UniversityFort Lauderdale, FL
American UniversityWashington, United States
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Who Is Running the Clinical Trial?
American UniversityLead Sponsor
Boston UniversityCollaborator
Massachusetts General HospitalCollaborator
Georgetown UniversityCollaborator
Nova Southeastern UniversityCollaborator
References
Patients report positive nutrition counseling outcomes. [2022]Assess outcomes of patient nutrition counseling.
A transferable programme of nutritional counselling for rehabilitation following myocardial infarction: a randomised controlled study. [2019]To evaluate the response to simple innovative dietary counselling in post myocardial infarction patients.
Promoting dietary change. [2016]The discouraging failure rate of counselling patients for dietary change suggests that traditional methods require some reconsideration. These have been frequently based on generalized assumptions regarding patients' health values, their need for knowledge, level of literacy, and ability to translate abstract concepts into daily food. Similarly, both patient and counsellor often insufficiently examine the environmental context of the dietary changes to determine whether or not they are feasible. This brief overview examines ways in which nutrition counselling can be enhanced to ensure that patients are enabled to develop a heart-healthy diet through active problem solving and directed development of self-efficacy in the skills they will need for lasting change.
A review of dietary interventions aimed at controlling hypertension. [2019]Before planning programs to change dietary behavior in groups of individuals, evidence about the effectiveness of different interventions is needed. Articles published in the journals indexed by Index Medicus between the years 1975-84 were reviewed for evidence concerning the effectiveness of dietary modification programs in achieving dietary change. All program evaluations published in English and aimed at control of blood pressure levels in adults were eligible for review. Twenty-nine articles relevant to the synthesis contained sufficient information evaluating the contribution of dietary intervention. These 20 studies addressed changes in fat consumption, reduction in salt intake and reduction in calories consumed. The methods of intervention ranged from residential programs, through individual counseling and group discussion involving spouses, to audiovisual tapes. The studies had varying periods of follow-up; among those with one or more years of follow-up, a number of studies were able to demonstrate effectiveness using different outcome measures. For some dietary components, notably changes in fat intake and reduction in salt consumption, it has been possible to identify a minimal effective intervention, such as self-help materials or individual instruction, while changes in calorie intake or weight seem to require group counseling with family member involvement. The findings from this information synthesis should prove useful to those planning dietary interventions.
Future prospects for adjunctive therapy: pharmacologic and nutritional approaches to immune system modulation. [2019]An increasingly large number of dietary components have been found to alter immune system function and, therefore, may be considered to have a pharmacologic effect (pharmacologic nutrition). Those dietary factors which have already been shown to influence outcome by producing a pharmacologic effect rather than correcting or preventing a simple deficiency include proteins (both type and amount), arginine, glutamine, omega-6 and omega-3 fatty acids, short-chain fatty acids, the metals iron and zinc, and the vitamins E, C, and A. Therapeutic outcome has already been influenced by dietary therapy (pharmacologic nutrition) in patients after burn injury or who have vascular diseases, and in experimental animals for the prevention of gut origin sepsis, the prevention and treatment of infection, prevention and development of secondary lesions in autoimmune diseases, augmentation of immunosuppression in transplantation, and in the treatment of cancer. Nutritional therapy using disease-specific formulations or supplements is an old idea now undergoing rapid evolution to increasing importance for successful therapeutic outcome.
The challenges of incorporation of omega-3 fatty acids into ration components and their prevalence in garrison feeding. [2017]Increasingly, private and military consumers are becoming aware of the positive benefits of a diet rich in omega-3 fatty acids (FAs) as health claims range from reducing inflammation to improving mood. The number of positive scientific articles supporting these claims is rapidly increasing, leading the military to examine the possibility of omega-3 supplementation for personnel. A variety of menus used either in shipboard or garrison feeding include fatty fishes that are rich in omega-3 FAs. However, omega-3 FAs have shelf-stability issues because of their susceptibility to oxidize; therefore, they create a challenge in terms of incorporation into ration components in nutritionally significant amounts. As a result, the Department of Defense Combat Feeding Directorate is investigating methods, technologies, and emerging products for incorporation of omega-3s into ration components. Based on existing research, fortification of foods with omega-3 FAs would improve nutritional quality as well as provide added benefit to the Warfighters.
Protecting military personnel from high risk dietary supplements. [2017]It is legal tomarketmost naturally occurring substances as dietary supplements in the USA without manufacturers demonstrating they are safe or effective, and an endless variety of ingredients, from esoteric botanicals to unapproved pharmaceuticals, can be found in dietary supplements. Use of certain supplements can pose a risk, but since a robust reporting systemdoes not exist in the USA it is difficult to know which are problematic and the number of adverse events (AE) resulting from their use. Certain populations, includingmilitary personnel, aremore likely to use dietary supplements than the general population. Approximately 70% of military personnel take dietary supplements while about 50% of civilians do. Service members prefer supplements purported to enhance physical performance such as supposedly natural stimulants, protein and amino acids, and combination products. Since some of thesemay be problematic, Servicemembers are probably at higher risk of injury than the general population. Ten percent of military populations appear to be taking potentially risky supplements, and the US Department of Defense (DoD) has taken variousmeasures to protect uniformed personnel including education, policy changes, and restricting sales. Actions taken include launching Operation Supplement Safety (OPSS), introducing a High Risk Supplement list, educating health care professionals on reporting AE thatmight be associated with dietary supplements, recommending policy for reporting AE, and developing an online AE reporting system. OPSS is a DoD-wide effort to educate service members, leaders, health care providers, military families, and retirees on how to safely select supplements
Scope of Use and Effectiveness of Dietary Interventions for Improving Health-Related Outcomes in Veterans: A Systematic Review. [2022]Military veterans often have numerous physical and mental health conditions and can face unique challenges to intervention and management. Dietary interventions can improve the outcomes in many health conditions. This study aimed to evaluate the scope of health conditions targeted with dietary interventions and the effectiveness of these interventions for improving health-related outcomes in veterans. A systematic literature review was performed following PRISMA guidelines to identify and evaluate studies related to veterans and dietary interventions. Five electronic databases were searched, identifying 2669 references. Following screening, 35 studies were evaluated, and 18 were related to a US national veteran weight-loss program. The included studies were critically appraised, and the findings were narratively synthesized. Study designs ranged from randomised controlled trials to cohort studies and were predominantly U.S. based. The intervention durations ranged from one to 24 months. The mean subject age ranged from 39.0 to 69.7 years, with often predominantly male participants, and the mean body mass index ranged from 26.4 to 42.9 kg/m2. Most dietary interventions for veterans were implemented in populations with overweight/obesity or chronic disease and involved single dietary interventions or dietary components of holistic lifestyle interventions. The most common primary outcome of interest was weight loss. The success of dietary interventions was generally moderate, and barriers included poor compliance, mental health conditions and large drop-out rates. The findings from this review illustrate the need for further refinement of dietary and lifestyle interventions for the management of veterans with chronic health conditions.
Dietary supplements: physician knowledge and adverse event reporting. [2015]Dietary supplement (DS) use among US military personnel is widespread. Many consume several different DS with multiple ingredients one or more times each week, representing a potential public health concern. The overall purpose of the study was to assess the knowledge and behaviors of health professionals and physicians regarding patterns of DS use and possible adverse events (AE) associated with DS use. We also determined how providers address the issue of DS with patients and evaluated provider knowledge regarding reporting systems.
Safety considerations with omega-3 fatty acid therapy. [2022]It has been suggested that the potential antithrombotic effect of fish oils may theoretically increase the risk for bleeding, which may be a safety concern for individual patients. However, clinical trial evidence has not supported increased bleeding with omega-3 fatty acid intake, even when combined with other agents that might also increase bleeding (such as aspirin and warfarin). Another potential safety concern is the susceptibility of omega-3 fatty acid preparations to undergo oxidation, which contributes to patient intolerance and potential toxicity. Finally, large amounts of fish consumption may result in adverse experiences due to the potential presence of environmental toxins such as mercury, polychlorinated biphenyls, dioxins, and other contaminants. The risks of exposure to environmental toxins and hypervitaminosis with fish consumption are substantially reduced through purification processes used to develop selected concentrated fish oil supplements and prescription preparations. Thus, in choosing which fish oil therapies to recommend, clinicians should be aware of available information to best assess their relative safety, which includes the US Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) advisory statement regarding fish consumption, the meaning of certain labeling (such as "verification" through the US Pharmacopeia) and the differences in FDA regulatory requirements between nonprescription fish oil supplements and prescription fish oil preparations, and how all of this is important to the optimal treatment of patients.
Prejudice and dietary counseling. [2016]Current medical practice requires us to be able to educate and alter an individual's approach to health maintenance. The objective is to prevent illness--not only to treat illness. This approach should result in keeping people out of hospitals and clinics. Diet should be thought of as a noun, not a verb. It is not synonymous with the corrective measures it supposedly sill insure, i.e., correct obesity, reduce hypertension, control blood lipid abnormalities. In keeping with this approach, USAF medical team members should be able to do dietary counseling. This paper will examine each of these topics, emphasizing dietary prejudice at the level of the counselor, the subject and his family, and the USAF medical team.
Adherence to protein restriction in patients with type 2 diabetes mellitus: a randomized trial. [2019]To describe the extent to which diet counselling can decrease protein intake, and to identify predictors of adherence.
Interdisciplinary treatment of a female outpatient population. Organizational model and preliminary results. [2019]To compare the efficacy of diet alone vs interdisciplinary therapy.
A computer-based dietary counseling system. [2018]A computer-based dietary counseling system is described. Designed to interact directly with patients, the program interviews people about their dietary behavior and plans with them a weight-reducing diet of approximately 1,500 kcal. In a preliminary trial, twenty-five volunteers gave critical commentary en route through the interviews. The results provided insight into the process of dietary interviewing by computer and helped in the preparation of an experimental study (10). It is our hope that a revised and expanded version of the program will be helpful to both patients and nutritionists in the management of a variety of clinically important dietary problems.