GINGER AND THE MICROBIOTA-GUT-BRAIN CONNECTION IN SCIATIC PAIN INDIVIDUALS

Neuropathic pain affects the quality of life of many Americans. Non-pharmacological strategies such as bioactive compounds in foods are being explored as therapeutics but can also serve as tools to better understand pain mechanisms. We previously reported that gingerols-enriched ginger (GEG) supplementation palliated pain-spectrum behaviors in animals with neuropathic pain via the microbiota-gut-brain axis. The proposed study is primarily designed to use GEG supplementation for the better understanding of the role of microbiota-gut-brain interactions in sciatica states in a randomized, double-blinded, and placebo-controlled trial. Eighty participants (40 lean and 40 obese with sciatica) will be randomized to receive placebo (2000 mg starch daily) or GEG (2000 mg daily) for 2 months. We will evaluate the effects of GEG supplementation on gut function measured as gut microbiota composition using 16S rRNA sequencing analysis, intestinal permeability based on plasma lipopolysaccharide binding protein and fecal zonulin using ELISA, and fecal metabolites using LC-MS/MS analysis (SA 1); on neuroinflammation in whole blood mRNA using nCounter® Neuroinflammation Panels analysis (SA 2); and on pain-associated outcomes and brain neuroplasticity by assessing functional (resting state-fMRI) and structural (Diffusion Tensor Imaging) connectivity, and correlations between pain and gut function, neuroinflammation, and brain neuroplasticity (SA 3). The study will monitor for safety, dietary intake, physical activity, and concomitant medication/OTC/therapies. The study addresses the program area of FY2022 Program Area Priority of Food Safety, Nutrition, and Health (A1343) priority: "Investigate components of foods and their impact on the gut microbiota to improve human health".