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Diet for Gulf War Syndrome

Phase 3

Recruiting

Led By Kathleen F Holton, PhD, MPH

Research Sponsored by American University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-month

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial studies how a special diet may help veterans with Gulf War Illness by studying changes in their nervous system and blood markers. Participants will have baseline measurements and then be randomly assigned to the diet or control group for one month.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a dietary intervention trial rather than a drug trial, side effects are not typical in the same way they are with medications. However, participants may experience changes in digestion or other bodily functions as their bodies adjust to new diets.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Global Impression of Change Scale (PGIC)

Total Symptom Score

Secondary study objectives

Biophotonic scanner

Brief Irritability Questionnaire (BITe)

Center for Epidemiological Studies Depression Scale (CES-D)

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Intervention

2014

Completed Phase 2

~2550

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