Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase II, double masked, randomized, placebo-controlled, two-arm study will evaluate cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness, along with assessments of safety of the intervention.
This is a study in Gulf War Veterans born between 1946 and 1978 who meet the modified Kansas and Centers for Disease Control and Prevention (CDC) case definitions for Gulf War Illness. This phase II, double-masked, randomized, placebo-controlled, two-arm study will focus on assessing cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness. 170 participants will be randomized 1:1 to receive either 12 weeks of the intervention (Bacopa) or placebo. Participants will be evaluated "remotely" via online assessment tools and telephone interviews, allowing participation from a nationwide catchment area. Primary assessment via the California Verbal Learning Test, Second Edition (CVLT-II) will occur at baseline and 12 weeks, along with laboratory assessments for all participants at baseline, and a self-selected subgroup at 12 weeks. Randomization to the intervention or placebo arms will be stratified by membership in the 12-week follow-up laboratory subgroup and sex. Laboratory draws will be performed at the participant's local clinical laboratory and will allow for measurements of putative biomarkers of neuron health and structural integrity along with biomarkers of inflammation and immune signaling. Monitoring phone calls will be made to the participant biweekly to assess safety. Participants will also undergo subjective assessments of physical health, vitality, sleep, pain, and symptom severity at baseline, 6, 12, and 16 weeks. Thus, participants will be observed through the treatment period (12 weeks) and for 4 weeks after completion to assess immediate effects and durability of the response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
170
BacoMind® (Bacopa monnieri standardized extract) 300 mg daily capsule.
Daily placebo capsule identical in size, color, and shape to that of the Bacopa capsules.
Nova Southeastern University
Davie, Florida, United States
RECRUITINGCalifornia Verbal Learning Test (CVLT-II) Assessment
Change in mean CVLT-II long delay free recall from baseline to 12 weeks. Higher CVLT-II scores are considered clinically better, and the raw CVLT-II scores will be used in analyses and reporting.
Time frame: 12 weeks
Blood Biomarker Concentrations
Putative biomarkers 18-plex cytokines, glutamate, brain-derived neurotrophic factor (BDNF), and neurofilament light chain (NfL) will be measured from blood drawn at baseline from all participants and then at 12 weeks from a subgroup of participants. Differences in the mean concentrations of each of the biomarkers will be assessed at the end of the intervention period in the 12 week blood draw subgroup.
Time frame: 12 weeks
Veterans RAND 36 Item Health Survey (VR-36©)
Change in mean VR-36 physical component score from baseline to 12 weeks. Normed values of the VR-36 physical component score (PCS) will be used based on US population estimates. The minimum score is 0 and the maximum score is 100. A higher score indicates better health outcomes.
Time frame: 12 weeks
Veterans RAND 36 Item Health Survey (VR-36©)
Change in mean VR-36 physical component score (PCS) from 12 weeks to 16 weeks. Normed values of the VR-36 PCS will be used based on US population estimates. The minimum score is 0 and the maximum score is 100. A higher score indicates better health outcomes.
Time frame: 16 weeks
Review of Treatment Related Adverse Events
Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.
Time frame: 16 weeks
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