Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
Condition: Persian Gulf Syndrome
MeSH terms: Syndrome; Persian Gulf Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12
      week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle
      strength outcomes in 100 GWI subjects.
    

Detailed description: 
      Background: Homocarnosine (beta-alanine - gamma-aminobutyric acid) is one of the most
      abundant dipeptides in the brain. It has important antioxidant properties. Both beta-alanine
      and GABA are neurotransmitters, suggesting that cleavage of this dipeptide by carnosine
      dipeptidase 1 (CNDP1) may have important regulatory functions in vivo.

      Drug: Homocarnosine is not available. Carnosine (beta-alanine - histidine) is an
      over-the-counter dietary supplement that shares the antioxidant properties. We proposed that
      oral carnosine would be absorbed from the gut, cross the blood brain barrier, reduce presumed
      brain oxidant stress that participated in illness pathology, and improve subject health.

      Hypothesis: Carnosine supplementation for 12 weeks by mouth in Gulf War Illness subjects
      would improve cognitive and other outcomes compared to placebo treatment.

      Subjects: Gulf War Illness subjects met 1996 Fukuda criteria for Chronic Multisymptom
      Illness.

      Design: Pilot study. Double blind randomized placebo controlled with comparisons between Week
      0 (Baseline, pre-randomization) and Week 12 (end of study) Outcomes: This pilot study
      included included cognitive testing, magnetic resonance imaging during the 2-back working
      memory task, self-report of psychometric and other subjective symptoms, tenderness testing by
      dolormetry, and pain threshold to assess reproducibility in the placebo-treated subjects, and
      potential treatment effects in the active study drug subjects. The study and each of the
      outcomes at weeks 0 and 12 are described in detail in the final published paper and in its
      extensive supplementary on-line materials (Baraniuk JN et al. Glob J Health Sci. 2013
      5:69-81. PMID:23618477 PMCID:PMC4209301).

      An improvement on accuracy on the 2-back working memory task between 0 and 12 weeks was the
      primary outcome.

      Other evaluations were secondary outcomes.
    

Intervention name(s): Carnosine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500mg Carnosine x2 daily; Microcrystalline cellulose placebo tablets x2 daily
Other intervention name(s): Pathway Carnosine supplied by Village Green Apothecary; Village Green Apothecary
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carnosine; antioxidant; Persian Gulf War; Gulf War Syndrome; GWI; Gulf War Illness; Exercise; Chronic Fatigue; Fibromyalgia; Veterans; Irritable Bowel Syndrome; Migraine headaches; Neuropathy; Multiple Chemical Sensitivity