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

What Was Tested

In this phase 2 trial, researchers set out to test Carnosine.

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.

It had two arms (groups): Carnosine treatment group (active comparator) and Placebo control group (placebo comparator).

Carnosine treatment group.

Placebo control group.

The registry classes the interventions as drug.

More on the Plan

Background: Homocarnosine (beta-alanine - gamma-aminobutyric acid) is one of the most abundant dipeptides in the brain.

It has important antioxidant properties.

Drug: Homocarnosine is not available.

Carnosine (beta-alanine - histidine) is an over-the-counter dietary supplement that shares the antioxidant properties.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to people of any sex aged from 34 years up to 82 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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:.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: pregnant women; active duty military personnel.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Carnosine and who got the comparison, which limits bias.

The Carnosine group and the comparison group ran side by side rather than switching.

As a double-blind Carnosine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-08 with completion listed for 2012-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores (time frame: Weeks 0 and 12). Incremental Change in Fatigue Score From Baseline to Week 12 (time frame: Week 0 and Week 12). SF36 Bodily Pain (time frame: Week 0 and Week 12).

It also tracked 1 secondary outcome, for example Digit Symbol Substitution (WAIS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Carnosine in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Carnosine compound page, all human trials.