Clinical Research Directory

Effects of Food Intake on Biomarker Activity in Normal Humans Taking Immulina

Sponsor: University of Mississippi Medical Center

Summary

The need for a generally available product that can safely and effectively increase antiviral resilience in susceptible populations became highly relevant during the recent COVID pandemic. The value continues with the endemic influenza season, which is now joined by COVID and, in susceptible adults, respiratory syncytial virus. The investigators recently completed a NIH-funded U19 project examining the immune potentiating effects of Immulina supplementation on biomarkers associated with antiviral resilience. Results showed robust NK responses in a substantial minority of participants. Further work has shown that the active compounds in Immulina (Braun-type lipoproteins) may be susceptible to degradation under GI conditions that are typically found during digestion after a meal (such as locally elevated intestinal pancreatic lipase and surfactant levels in the post meal state). In the investigators initial study, no instruction was given about when to take the investigational product in relationship to a meal or any restrictions on fat content indicating a possible spectrum of intestinal chemical conditions that could have affected the bioactivity of Immulina in different members of the study cohort. Because of the heterogeneous immune biomarker response in the investigators U19 study cohort, the investigators propose to explore the role of food presence when ingesting the supplement and its possible impact on the immunostimulatory properties of Immulina. The investigators will address this question by seeking to characterize and optimize the oral delivery of Immulina through evaluating product quality, bio accessibility, and stability under simulated GI conditions relevant to fasting and fed states. This will be accomplished through botanical authentication, bioassay-based standardization, and dissolution performance of the clinical encapsulated product to ensure consistency with previously characterized material. Additionally, investigators will perform in vitro studies to identify dietary conditions most likely to preserve Immulina activity. Further, an additional pharmacodynamic study will be performed with various Immulina doses over four weeks in individuals who will fast for 2 hours or have just completed a meal after taking daily dose of Immulina to compare the effects of fed vs 2 hr. fasting after ingesting Immulina on biomarkers of antiviral resilience. Finally, investigators will examine the effects of a 4-week pretreatment with Immulina vs. placebo on vaccine-specific antibody titers after routine influenza immunization by comparing vaccine-specific antibody titers immediately prior and 4 weeks after immunization. These studies will allow optimal design of future clinical trial protocols to assess impact of daily Immulina on antiviral resilience in susceptible populations with or without known immune compromise due to concomitant disease (e.g. cancer, transplant, etc.) or age (e.g., immune senescence).

Official title: Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection: Defining Dietary Conditions That Influence Clinical Responsiveness

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