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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Global Impression of Change Scale (PGIC)

Total Symptom Score

Secondary outcome measures

Biophotonic scanner

Brief Irritability Questionnaire (BITe)

Center for Epidemiological Studies Depression Scale (CES-D)

+7 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

American UniversityLead Sponsor

19 Previous Clinical Trials

4,605 Total Patients Enrolled

1 Trials studying Gulf War Syndrome

40 Patients Enrolled for Gulf War Syndrome

Boston UniversityOTHER

455 Previous Clinical Trials

9,941,465 Total Patients Enrolled

2 Trials studying Gulf War Syndrome

270 Patients Enrolled for Gulf War Syndrome

Massachusetts General HospitalOTHER

2,935 Previous Clinical Trials

13,198,481 Total Patients Enrolled

Media Library

Dietary Intervention (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05675878 — Phase 3

Gulf War Syndrome Research Study Groups: Dietary Intervention Group, Waitlisted Control Group

Gulf War Syndrome Clinical Trial 2023: Dietary Intervention Highlights & Side Effects. Trial Name: NCT05675878 — Phase 3

Dietary Intervention (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675878 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this clinical trial higher than fifty years?

"To be eligible to enter this study, participants must fall into the age range of 50 to 75. For those below 18 and above 65, there are separate trials with 14 and 2 people involved respectively."

Answered by AI

Has the Dietary Intervention Group received authorization from the FDA?

"There is empirical evidence suggesting that the Dietary Intervention Group has a high safety profile, thus garnering it a score of 3."

Answered by AI

Are there still opportunities to participate in the research initiative?

"According to the clinicaltrials.gov database, this medical investigation is presently seeking individuals for participation. This study was initially publicized on March 1st 2023 and a recent update occurred on July 18th 2023."

Answered by AI

What is the upper limit of individuals enrolled in this research program?

"One hundred sixty suitable candidates are needed to partake in this research. Eligible enrollees can register at two major sites - Nova Southeastern University, Fort Lauderdale, Florida and Boston University located in Massachusetts."

Answered by AI

What is the primary goal of this clinical experiment?

"To assess the primary outcome of this trial, which will be monitored over a one month period, the Patient Global Impression of Change Scale (PGIC) is employed. Secondary outcomes being evaluated include Cognitive Tests to appraise cognitive function through computerised software and an in-person exam; Dolorimetry where pressure is implemented on 18 parts of the body that are usually tender for chronic pain conditions; and Biophotonic Scanner utilising infrared light shone via the index finger as a noninvasive method to measure long-term dietary carotenoid consumption with higher scores indicating greater intake."

Answered by AI

Are there any criteria which would allow me to participate in this trial?

"This clinical trial seeks to enrol 160 individuals, aged between 50 and 75 years old, who have been diagnosed with Gulf War Syndrome. Applicants must be of any gender or ethnicity and satisfy the criteria outlined by both the Center for Disease Control (CDC) and Kansas. Furthermore, they will need to maintain a stable medication regimen throughout their participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Confirmation of Diet as a Treatment for Gulf War Illness

Kathleen Holton 2023. "Confirmation of Diet as a Treatment for Gulf War Illness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05675878.

All > Gulf War Illness