RECRUITING

Confirmation of Diet as a Treatment for Gulf War Illness

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Confirmation of Diet as a Treatment for Gulf War Illness

Quick Facts

Study Start:2023-03-01
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05675878

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and Females of all races and ethnicities who are ≤75 yrs of age
  2. * Served in the 1990-1991 Persian Gulf War
  3. * Fulfill both Center for Disease Control (CDC) and Kansas definitions of Gulf War Illness
  4. * Stable medication regimen for ≥1 month and willing to keep medications and supplements stable throughout study participation
  1. * Recent substance use disorder (past year)
  2. * Unwilling to stop using alcohol, tobacco (including vaping) and/or marijuana; or unwilling to change diet
  3. * Diagnosed seizure disorder or severe asthma requiring past hospitalization
  4. * Currently taking medication which affects glutamatergic or GABAergic neurotransmission (but can work with their physician to wean off of these medications prior to participating)

Contacts and Locations

Study Contact

Houra Taheri, PhD
CONTACT
202- 885-3810
htaheri@american.edu
Kathleen F Holton, PhD, MPH
CONTACT
202-885-3797
holton@american.edu

Principal Investigator

Kathleen F Holton, PhD, MPH
PRINCIPAL_INVESTIGATOR
American University

Study Locations (Sites)

American University
Washington, District of Columbia, 20016
United States
Nova Southeastern University
Fort Lauderdale, Florida, 33314
United States
Boston University
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: American University

  • Kathleen F Holton, PhD, MPH, PRINCIPAL_INVESTIGATOR, American University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Gulf War Illness
  • GWI
  • Gulf War Syndrome
  • Diet
  • Treatment

Additional Relevant MeSH Terms

  • Gulf War Syndrome
  • Gulf War Illness