The USDA trypsin inhibitor study. I. Background, objectives, and procedural details

Short-term feeding studies have shown that raw soy flour and purified trypsin inhibitors (TI) cause pancreatic hypertrophy and hyperplasia in certain monogastric animals. Prolonged exposure to high levels of TI in raw soy ultimately leads to pancreatic nodular hyperplasia and acinar cell adenoma in rats exposed to low levels of pancreatic carcinogens. Such change has been observed even in the absence of any exposure to known carcinogens. These results emphasized the need for chronic (2 yr) feeding trials which would clearly reveal dose response relationships of alterations in pancreatic pathology to dietary TI and possible interactions with dietary protein and fat.