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Confirmation of Diet as a Treatment for Gulf War Illness

NCT05675878 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-07-09

No results posted yet for this study

Summary

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.

Conditions

  • Gulf War Syndrome
  • Gulf War Illness

Interventions

BEHAVIORAL

Dietary Intervention

This is a whole food, nutrient-dense diet that aims to remove exposure to specific food additives thought to have negative neurological effects, while also optimizing micronutrient intake.

Sponsors & Collaborators

  • Boston University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Georgetown University

    collaborator OTHER

  • Nova Southeastern University

    collaborator OTHER

  • American University

    lead OTHER

Principal Investigators

  • Kathleen F Holton, PhD, MPH · American University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-08-31
Completion
2025-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05675878 on ClinicalTrials.gov