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临床试验/NCT05675878
NCT05675878招募中3 期

Confirmation of Diet as a Treatment for Gulf War Illness

American University6 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
160
试验地点
6
主要终点
Total Symptom Score

研究概览

简要总结

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.

详细描述

The rationale for the proposed research comes from observations from a smaller study which demonstrated profound widespread symptom improvements in veterans with Gulf War Illness (GWI) after one month on the diet. Improvements were noted in every symptom domain and included significant reductions in overall symptom number (with an average of 9 symptoms going away), reduced pain, fatigue, depression, anxiety, and post-traumatic stress disorder (PTSD); and concurrent significant improvements in cognitive function and quality of life. Results also demonstrated that those who improved on the diet had a significant reduction in peripheral inflammation, as compared to those who did not improve on the diet. These benefits have been observed without any negative side effects and the majority of participants continued to follow the diet three months after study completion, suggesting continued improvement and good feasibility. The objectives of this study are: 1) to evaluate whether or not the substantial benefits observed in the recently completed clinical trial hold in a larger group of more diverse veterans with GWI, and 2) to identify blood and/or brain measures which predict improvement on the diet. By recruiting a large group of veterans which are representative of those with GWI, the findings of this research should be applicable to the larger GWI community. The impact of this research could be quite profound, with the diet being a no-risk, low-cost treatment option with no side effects, which allows each individual veteran to take back control of his/her health. There are no direct risks to following the diet since it is a healthy whole-food dietary approach which provides all necessary nutrients. The potential benefits of the diet include improvement in GWI symptoms; improvement in quality of life, potential for improvement in other health markers related to diet (such as obesity, diabetes, cardiovascular disease, high blood pressure) and the possibility of benefit to the larger community. If positive results are confirmed in the proposed study, then the next step would be to teach all Veterans Administration (VA) dietitians how to administer the low glutamate diet so that all veterans have access to it, which should be possible within 1-2 years of the completion of this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and Females of all races and ethnicities who are ≤75 yrs of age
  • Served in the 1990-1991 Persian Gulf War
  • Fulfill both Center for Disease Control (CDC) and Kansas definitions of Gulf War Illness
  • Stable medication regimen for ≥1 month and willing to keep medications and supplements stable throughout study participation

排除标准

  • Recent substance use disorder (past year)
  • Unwilling to stop using alcohol, tobacco (including vaping) and/or marijuana; or unwilling to change diet
  • Diagnosed seizure disorder or severe asthma requiring past hospitalization
  • Currently taking medication which affects glutamatergic or GABAergic neurotransmission (but can work with their physician to wean off of these medications prior to participating)

结局指标

主要结局

Total Symptom Score

时间窗: 1-month

This measure computes the number of symptoms being experienced in this widespread chronic pain condition, and also computes a score based on severity of each symptom. The raw symptom score ranges from 0-32, and the symptom severity score ranges from 0-96, with higher scores indicative of worse outcomes.

Patient Global Impression of Change Scale (PGIC)

时间窗: 1-month

The PGIC is a self-report measure of the amount of change experienced from the treatment using a 7-point scale with the following options: very much worse, much worse, a little worse, no change, a little better, much better, very much better.

次要结局

  • Chalder Fatigue Score(1-month)
  • Veterans RAND 36 Item Health Survey (VR-36)(1-month)
  • Brief Irritability Questionnaire (BITe)(1-month)
  • Generalized Anxiety Disorder Scale (GAD-7)(1-month)
  • Biophotonic scanner(1-month)
  • McGill Pain Questionnaire(1-month)
  • Center for Epidemiological Studies Depression Scale (CES-D)(1-month)
  • Cognitive Testing(1-month)
  • PTSD Checklist for DSM-5 (PCL-5)(1-month)
  • Dolorimetry(1-month)

研究者

发起方
American University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Holton

Associate Professor

American University

研究点 (6)

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