Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)

Georgetown University

Status and phase: Completed; Phase 2

Conditions: Persian Gulf Syndrome

Treatments: Drug: Carnosine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00810368

2008-068

HRPO Log No. A-14542.2 (Other Identifier)

USAMRMC PR# W91ZSQ-7149-N602 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 34 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

  • Persian Gulf waters and adjacent land areas,
  • Other global locations, or,
  • U.S. only. 1990-1991 enlistment status:
  • Active duty
  • National Guard
  • Reserves

Exclusion criteria

• HIV/AIDS
• Pregnant Women
• Active Duty Military Personnel
• Children
• Incarceration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Carnosine treatment group

Active Comparator group

Description:

Carnosine treatment group

Treatment:

Drug: Carnosine

Placebo control group

Placebo Comparator group

Description:

Placebo control group

Treatment:

Drug: Placebo