Diet for Gulf War Syndrome

Recruiting at 2 trial locations

Overseen By Kathleen F Holton, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: American University

Must not be taking: Glutamatergic, GABAergic

Disqualifiers: Substance use disorder, Seizure, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

160 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{4 11 12 13 14}

Research Team

Kathleen F Holton, PhD, MPH

Principal Investigator

American University

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.

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.

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

Trial Overview The 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

Group I: Dietary Intervention Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

American University

Lead Sponsor

Trials

22

Recruited

5,600+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Nova Southeastern University

Collaborator

Trials

103

Recruited

12,000+

Findings from Research

A study involving 400 adult patients showed that 83% of participants reported making dietary modifications after nutrition counseling, indicating effective communication and understanding of dietary advice.

Patients who received counseling felt better emotionally (57%) and physically (37%), and 64% felt more in control of their health, highlighting the positive impact of nutrition counseling on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients report positive nutrition counseling outcomes. Schiller, MR., Miller, M., Moore, C., et al.[2022]

A randomized controlled trial involving 98 post-myocardial infarction patients showed that simple dietary counseling significantly improved diet composition at 12 weeks, with 65% of participants meeting the target of five portions of fruits and vegetables daily compared to only 31% in the control group.

While the dietary improvements were notable shortly after the intervention, they were not sustained after one year, indicating the need for a more long-term program to maintain these healthy eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A transferable programme of nutritional counselling for rehabilitation following myocardial infarction: a randomised controlled study. Leslie, WS., Hankey, CR., Matthews, D., et al.[2019]

Traditional dietary counseling methods often fail because they rely on generalized assumptions about patients' health values and abilities, which may not reflect individual needs.

Enhancing nutrition counseling by focusing on active problem-solving and building self-efficacy can help patients successfully adopt and maintain a heart-healthy diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting dietary change. Crawford, S.[2016]

A review of 29 studies on dietary modification programs aimed at controlling blood pressure in adults found that interventions like self-help materials or individual instruction can effectively reduce fat and salt intake.

For more significant changes in calorie intake or weight, group counseling that includes family members is necessary, highlighting the importance of social support in dietary behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of dietary interventions aimed at controlling hypertension. Bender, DE., Beresford, SA., McFall, SL.[2019]

Dietary components can significantly influence immune system function, acting as pharmacologic agents rather than just preventing deficiencies, with specific nutrients like proteins, omega-3 fatty acids, and vitamins showing notable effects.

Nutritional therapy has been effective in improving outcomes for various conditions, including burn injuries and vascular diseases, and is gaining recognition for its role in preventing infections and supporting cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future prospects for adjunctive therapy: pharmacologic and nutritional approaches to immune system modulation. Alexander, JW., Peck, MD.[2019]

Omega-3 fatty acids (FAs) are recognized for their health benefits, including reducing inflammation and improving mood, prompting the military to consider omega-3 supplementation for personnel.

The Department of Defense is exploring methods to incorporate omega-3s into military rations, as their nutritional benefits could enhance the overall quality of food provided to Warfighters, despite challenges related to their shelf stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenges of incorporation of omega-3 fatty acids into ration components and their prevalence in garrison feeding. Davis, BA., Prall, BC.[2017]

Approximately 70% of military personnel use dietary supplements, which is significantly higher than the 50% usage rate in the general civilian population, potentially increasing their risk of adverse events.

The US Department of Defense has implemented measures like Operation Supplement Safety to educate military personnel about safe supplement use and to monitor and report adverse events associated with dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protecting military personnel from high risk dietary supplements. Deuster, PA., Lieberman, HR.[2017]

A systematic review of 35 studies on dietary interventions for military veterans showed that these interventions primarily target overweight/obesity and chronic diseases, with a focus on weight loss as the main outcome.

While dietary interventions demonstrated moderate success in improving health outcomes, challenges such as poor compliance and high dropout rates highlight the need for better-tailored programs to address the unique needs of veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scope of Use and Effectiveness of Dietary Interventions for Improving Health-Related Outcomes in Veterans: A Systematic Review. Mellor, R., Saunders-Dow, E., Mayr, HL.[2022]

A significant number of military physicians (60%) reported observing adverse events related to dietary supplements, but only 18% of them actually reported these events, highlighting a gap in adverse event reporting.

Most physicians (66%) routinely inquire about dietary supplement use with their patients, yet 65% lack a reliable source of information on these products, indicating a need for better education and resources regarding dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplements: physician knowledge and adverse event reporting. Cellini, M., Attipoe, S., Seales, P., et al.[2015]

Clinical trials have shown that omega-3 fatty acid intake from fish oils does not increase the risk of bleeding, even when taken with other blood-thinning medications like aspirin and warfarin, suggesting it is safe for patients.

Purified fish oil supplements significantly reduce the risks associated with environmental toxins and hypervitaminosis, making them a safer option compared to consuming large amounts of fish, which may contain harmful contaminants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations with omega-3 fatty acid therapy. Bays, HE.[2022]

The focus of modern medical practice should shift from merely treating illnesses to actively preventing them through education and lifestyle changes, particularly in diet.

Diet should be viewed as a fundamental aspect of health maintenance rather than just a temporary solution for conditions like obesity or hypertension, highlighting the need for USAF medical team members to provide effective dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prejudice and dietary counseling. Obrien, MS.[2016]

Diet counseling for protein restriction in 125 type 2 diabetic patients led to a modest decrease in protein intake, with reductions of 8 g/day and 15 g/day at 6 months according to urinary urea excretion and food-frequency questionnaires, respectively.

Factors such as satisfaction with the pre-existing diet, lower body weight, and living alone were associated with better adherence to protein restriction, but these factors only explained a small portion (11%) of the variation in adherence levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to protein restriction in patients with type 2 diabetes mellitus: a randomized trial. Pijls, LT., de Vries, H., van Eijk, JT., et al.[2019]

In a study of 256 women, those receiving interdisciplinary therapy showed significantly better adherence to follow-up check-ups (78.44%) compared to those on diet alone (50.65%), indicating that interdisciplinary approaches may enhance patient engagement.

After 8 weeks, the interdisciplinary therapy group lost an average of 5.88 kg, while the diet-only group lost 4.18 kg, suggesting that a comprehensive treatment approach may lead to greater weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary treatment of a female outpatient population. Organizational model and preliminary results. Boschi, V., Siervo, M., Nasti, G., et al.[2019]

A computer-based dietary counseling system was developed to interact with patients and help them create a weight-reducing diet of about 1,500 kcal, aiming to improve dietary behavior.

In a preliminary trial with 25 volunteers, feedback was gathered to enhance the dietary interviewing process, indicating potential for the program to assist both patients and nutritionists in managing dietary issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computer-based dietary counseling system. Witschi, J., Porter, D., Vogel, S., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patients report positive nutrition counseling outcomes. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A transferable programme of nutritional counselling for rehabilitation following myocardial infarction: a randomised controlled study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Promoting dietary change. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A review of dietary interventions aimed at controlling hypertension. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Future prospects for adjunctive therapy: pharmacologic and nutritional approaches to immune system modulation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The challenges of incorporation of omega-3 fatty acids into ration components and their prevalence in garrison feeding. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Protecting military personnel from high risk dietary supplements. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Scope of Use and Effectiveness of Dietary Interventions for Improving Health-Related Outcomes in Veterans: A Systematic Review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary supplements: physician knowledge and adverse event reporting. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Safety considerations with omega-3 fatty acid therapy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Prejudice and dietary counseling. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Adherence to protein restriction in patients with type 2 diabetes mellitus: a randomized trial. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

Interdisciplinary treatment of a female outpatient population. Organizational model and preliminary results. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

A computer-based dietary counseling system. [2018]