A Double-Blind Clinical Study to Investigate the Effects of a Fungal Protease Enzyme System on Metabolic, Hepato-renal, and Cardiovascular Parameters Following 30 Days of Supplementation in Active, Healthy Men

Research on the role of digestion in overall health has driven increasing interest in the use of digestive enzymes, which may improve nutrient absorption and reduce gastrointestinal symptoms. Sales of digestive aids and enzymes have grown over 8% in 2009, with enzymes accounting for $69 million of this growing category. Recent clinical research reported that acute dosing of Aminogen®, a patented blend of digestive protease enzymes isolated from Aspergillus and blended with whey protein concentrate, increased the rate of protein absorption. The results indicated a faster rate of amino acid absorption reflected in significantly higher blood levels of amino acids, increased nitrogen retention, and significantly reduced levels of C-reactive protein. Few studies, however, have examined the safety of repeated dosing of oral enzymes with an appropriate substrate. The purpose of this study, therefore, was to evaluate basic measures of clinical safety during 30 days of continuous, repeated dosing of Aminogen® and whey protein supplementation in healthy, active men maintaining a regimen of resistance training. Parameters evaluated include various markers of general physical health, metabolic function, hepato-renal function, and cardiovascular health including fasting blood lipids. Forty healthy, resistance-trained men (27.1 ± 7.9 years) were recruited for this double-blind, randomized study. Group A ingested two 40-g doses of whey protein per day containing Aminogen®. Group B ingested two 40-g doses of whey protein per day. No significant changes were noted in measures of general physical health, metabolic function, cardiovascular health, and hepato-renal function within or between groups. However, total cholesterol, LDL cholesterol, and serum calcium significantly increased (P < 0.05) in group B. In group A, whey protein containing Aminogen® was well tolerated with no adverse reactions reported. No differences in serum markers of clinical safety and an improved blood lipid profile are also reported.