DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Overview | Drugs | Nutraceuticals & Probiotics | Complementary & Alternative Medicine | CNS Stimulation


Nutraceuticals & Probiotics

GW060036

Q10 for Gulf War Veterans

Summary: In this pilot trial, GWI participants were given placebo or low or high doses of coenzyme Q10 (ubiquinol) for 3 months. The low dose group (100 mg/d) subset of males significantly benefited in self-rated health improvement versus placebo. Physical function in the male subset also improved. The study demonstrated benefit to symptomatic Gulf War veterans that warranted further study. The ubiquinone form of CoQ10 is now being studied in a Phase II study sponsored by the VA.

ClinicalTrials.gov Identifier: NCT01011348

Status (2021): COMPLETED

GW060044

Title: CNDP1 Polymorphisms and Carnosine Therapy in GWI

Summary: Cerebrospinal fluid proteomics studies of ill Gulf War veterans identified carnosine dipeptidase 1 (CNDP1) as prevalent in the cohort. This study examined the utility of carnosine treatment to improve GWI symptoms. There were no appreciable differences between the carnosine-treated and placebo groups (n=25) except one cognitive performance test and diarrhea severity.

ClinicalTrials.gov Identifier: NCT00810368 and NCT00810225

Status (2021): COMPLETED

GW130015

Treating Gulf War Illness with Novel Anti-Inflammatories: A Screening of Botanical Microglia Modulators

Summary: Of nine botanical agents tested, four showed a significant impact on GWI symptoms over both baseline and placebo conditions. These agents are: Resveratrol, Stinging nettle, Pycnogenol, and Curcumasorb.

ClinicalTrials.gov Identifier: NCT02909686

Status (2021): COMPLETED

GW093043

Probiotic (VSL#3) for Gulf War Illness

Summary: This study will demonstrate the safety and effectiveness of a probiotic (VSL #3) in the treatment of IBS and non-intestinal symptoms of IBS which are indistinguishable from Gulf War Illness.

ClinicalTrials.gov Identifier: NCT02011542

Status (2021): COMPLETED

GW130070

Development of Dietary Polyphenol Preparations for Treating Veterans with Gulf War Illness

Summary: This pilot study aims to test the potential efficacy of dietary supplementation with a flavonoid-rich preparation of flavonoids to help alleviate chronic fatigue and protect against cognitive deficits in Gulf War illness.

ClinicalTrials.gov Identifier: NCT02915237

Status (2021): COMPLETED

GW140146

Extending Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness

Summary: Veterans with Gulf War Illness show evidence of impaired bioenergetics. This study treats this dysfunction with coenzyme Q10 and an individualized cocktail of vitamins and nutraceuticals to address mitochondrial dysfunction and related health issues.

ClinicalTrials.gov Identifier: NCT02804828

Status (2021): OPEN

GW140153

Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin

Summary: This pilot study will evaluate two nutraceuticals known to downregulate NF-kB, comparing each to placebo. If successful, this study will support a nutraceutical-based therapy for ill Gulf War veterans and support the PI’s computational clinical trials model.

ClinicalTrials.gov Identifier: NCT02848417

Status (2021): OPEN

GW160050

A Pilot RCT on the Effect of Resveratrol on Mood, Memory Deficits, Hippocampal Inflammation, and Neurogenesis in Veterans with Gulf War Illness (GWI)

Summary: This pilot trial will examine the efficacy of resveratrol, which is known to have robust antioxidant and anti-inflammatory properties to relieve many of the deficits attributed to GWI, including cognitive and mood dysfunction and hippocampal oxidative stress and inflammation.

ClinicalTrials.gov Identifier: NCT03665740

Status (2021): Enrollment Complete; analyzing results

GW180045

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Oleoylethanolamide for Targeting Lipid Metabolism in Gulf War Illness

Summary: One of the pathogenic mechanisms in GWI involves impaired lipid metabolism, which corresponds with brain glia activation and inflammation. It is anticipated that oleoylethanolamide (OEA) will restore blood lipid profiles and lower inflammation, which will improve the general health of veterans with GWI, reducing fatigue and pain and improving memory performance.

ClinicalTrials.gov Identifier: Pending

Status (2021): OPEN

GW170044

Phase II Study of Bacopa in Gulf War Illness

Summary: A double-blinded Phase II study in 264 participants who meet the modified Kansas and CDC criteria for Gulf War illness. Participants will be assessed for improved cognitive function outcomes and clinical/laboratory measures after being administered Bacopa monerii.

ClinicalTrials.gov Identifier: NCT04927338

Status (2021): PENDING

GW170044

Physical health function and oxidative stress after antioxidant treatment in GWI: N-Acetyl Cysteine (NAC)

Summary: This Phase II study will test if N-Acetyl Cysteine (NAC) promotes central nervous system recovery from chronic oxidative stress and depletion of antioxidants in Gulf War illness. The study aims to result in improved physical function after 12 weeks of NAC supplementation, compared with placebo.

ClinicalTrials.gov Identifier: NCT04987775

Status (2021): PENDING

GW190036

A Randomized Double-Blind Placebo-Controlled Clinical Trial of Nicotinamide Riboside for Restoring Mitochondrial Bioenergetics in Gulf War Illness

Summary: A Phase II trial of Nicotinamide Riboside, a member of the B3 vitamin family, to support cellular bioenergetics and improve health for ill Gulf War veterans by reducing fatigue and improving memory performance.

ClinicalTrials.gov Identifier: Pending

Status (2021): PENDING

GW190064

Coenzyme Q10 for Gulf War Illness: A Replication Study

Summary: A confirmatory Phase 3 study for Coenzyme Q10 (ubiquinone) to validate its ability to improve symptoms, physical function and self-rated health in veterans with GWI.

ClinicalTrials.gov Identifier: Pending

Status (2021): PENDING



Last updated Thursday, May 26, 2022