UPSN Included In Food Reduces Aflatoxin Bioavailability In a Crossover Study In Ghana.

Uniform Particle Size NovaSil (UPSN), a calcium montmorillonite, has high binding affinity for aflatoxin B₁ (AFB₁) a naturally occurring hepatocarcinogen. AFB₁ is a secondary metabolite of Aspergillus flavus and A. parasiticus. Aflatoxin exposure occurs in sub-Saharan Africa and Southeast Asia due to favorable climate for Aspergillus growth and economic burdens within the communities. Populations in Ghana are chronically exposed to AFB₁ year-round, possibly influencing the country’s high hepatocellular carcinoma mortality rate. In this crossover study, participants (46) from the Ejura district were provided with common Ghanaian meals twice/day. Participants were split into two groups receiving 3g/day of either UPSN treatment or placebo mixed in with their food for 10 days. Participants were switched to the opposite treatment group halfway (after 5 days) through the study. Palatability questionnaires were conducted each day and urine samples collected each morning. AFM₁ biomarkers of exposure were extracted from urine using AflaTest® immunoaffinity columns and measured using HPLC analysis with fluorescence detection. During the screening process (baseline) AFM₁ was detected in 100% of the population with levels ranging from 15.03-5,454.88 pg/mg creatinine. During treatment, the placebo group had higher levels of AFM₁ than UPSN treated participants and the data illustrates the switch from placebo to UPSN treatment and vice versa. No adverse events resulted from treatment and the application of UPSN in food was well received with the taste, aroma and texture all scoring highly on the questionnaires. These results suggest that the inclusion of UPSN clay in foods can considerably reduce aflatoxin bioavailability and risk in a dose form that is easy, economical and culturally acceptable. This clay can potentially impact the health and livelihood of populations in developing countries where staple crops are often contaminated with aflatoxin (Supported by USAID-PCRSP TAM149 and NIH 1R01MD005819-01).