Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 34 - 82 |
| Updated: | 5/10/2018 |
| Start Date: | August 2008 |
| End Date: | July 2012 |
Carnosine Versus Placebo Treatment Study in Gulf War Illness (GWI)
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.
week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle
strength outcomes in 100 GWI subjects.
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.
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.
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
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