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

NCT00810368 | Completed Phase 2 Results

• 3 other identifiers: 2008-068USAMRMC PR# W91ZSQ-7149-N602HRPO Log No. A-14542.2
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persian Gulf Syndrome

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

Outcome Measures

Primary Outcomes (6)

• Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores

  CFS Severity Score (Δ ≥ 5 / 36) (Baraniuk et al., 1998; Baraniuk et al., 2000a; Baraniuk, Naranch, Maibach, \& Clauw, 2000b). Subjects scored the severity of the 9 CFS criteria (Fatigue, memory/concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbances, exertional exhaustion from Fukuda et al. 1994) on a scale of none (score=0), trivial (1), mild (2), moderate (3) and severe (4). The sum was 36. Individuals taking carnosine were predicted to show a decrease of ≥ 5 at week 12 compared to week 0, compared to no change for placebo subjects. 2-tailed paired t-tests were used to determine significant incremental changes for individuals in the carnosine group compared to the placebo group.

  Weeks 0 and 12

• Subjects With Improved Diarrhea Symptoms

  Patients were given questionnaires assessing common symptom complaints of diarrhea.

  Weeks 0 and 12

• Incremental Change in Fatigue Score From Baseline to Week 12

  Instantaneous Fatigue was scored as none (0) to severe (10) at week 0 and week 12. The difference between the Week 12 minus the Week 0 values was the incremental change. If the incremental change was greater than 0, then the Instantaneous Fatigue was worse at week 12 than week 0. If the incremental change was less than 0, then the Instantaneous Fatigue was improved at week 12 compared to week 0. The total potential range for incremental change was from -10 to +10.

  Week 0 and Week 12

• SF36 Bodily Pain

  Incremental change in Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score from baseline to week 12. The Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score ranges from 0 (very bad bodily pain) to 100 (no bodily pain). The incremental change was the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at week 12 minus the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.

  Week 0 and Week 12

• Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12

  Each item on the Generalized Anxiety Scale (GAD) scores was scored as none (0), trivial (1), mild (2), moderate (3), or severe (4) and the sum of the 7 items calculated (range 0 to 28). The incremental change between Week 0 and Week 12 was determined for each treatment.

  Week 0 and Week 12

• Incremental Change in SF36 General Health Between Baseline and Week 12

  Incremental change in SF36 General Health score from baseline to week 12. The SF36 General Health score ranges from 0 (very bad General Health) to 100 (very good General Health). The incremental change was the SF36 General Health score at week 12 minus the SF36 General Health score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for SF36 General Health score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the SF36 General Health score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.

  Week 0 and Week 12

Secondary Outcomes (1)

• Digit Symbol Substitution (WAIS)

  Difference between Week 0 and Week 12 (end of study)

Study Arms (2)

Carnosine treatment group

ACTIVE COMPARATOR

Carnosine treatment group

Drug: Carnosine

Placebo control group

PLACEBO COMPARATOR

Placebo control group

Drug: Placebo

Interventions

Carnosine DRUG

500mg Carnosine x2 daily

Also known as: Pathway Carnosine supplied by Village Green Apothecary

Carnosine treatment group

Placebo DRUG

Microcrystalline cellulose placebo tablets x2 daily

Also known as: Village Green Apothecary

Placebo control group

Eligibility Criteria

• Age: 34 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (5)

• Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. doi: 10.1093/aje/155.11.1033.

  PMID: 12034582 BACKGROUND

• Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22. doi: 10.1186/1471-2377-5-22.

  PMID: 16321154 BACKGROUND

• Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Koppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7. doi: 10.2337/diabetes.54.8.2320.

  PMID: 16046297 BACKGROUND

• Chez MG, Buchanan CP, Aimonovitch MC, Becker M, Schaefer K, Black C, Komen J. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. J Child Neurol. 2002 Nov;17(11):833-7. doi: 10.1177/08830738020170111501.

  PMID: 12585724 BACKGROUND

• Baraniuk JN, El-Amin S, Corey R, Rayhan R, Timbol C. Carnosine treatment for gulf war illness: a randomized controlled trial. Glob J Health Sci. 2013 Feb 4;5(3):69-81. doi: 10.5539/gjhs.v5n3p69.

  PMID: 23618477 RESULT

Related Links

• Laboratory Website

MeSH Terms

Conditions

Persian Gulf Syndrome; Motor Activity; Fibromyalgia; Irritable Bowel Syndrome; Migraine Disorders; Multiple Chemical Sensitivity

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Behavior; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Environmental Illness; Hypersensitivity; Immune System Diseases; Disorders of Environmental Origin

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Small sample sizes. No measure of changes in brain carnosine/homocarnosine/GABA. Subjective outcomes were insensitive to change. Stool consistency needed better scoring system.

Results Point of Contact

• Title: Dr. James N Baraniuk
• Organization: Georgetown University Medical Center

baraniuklab@gmail.com

202-687-8231

Study Officials

• James N Baraniuk, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 28, 2019
• Results First Posted: August 18, 2016

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)