30-5


Clinical trials to prove biological activity

L. DAVIS, Davisco Foods International, Inc., 11000 W. 78th St., Ste. 210, Eden Prairie, MN 55344

Whey proteins are rich in components that have been proven and have potential to have unique biological activity. Once the whey protein derived components are isolated and purified on a commercial scale, the biological activity must be proven in vitro and in vivo. The ultimate proof of the efficacy of the biological activity of these whey protein derived components is to conduct clinical trials using specifically selected participants.

Hypertension is an independent and prevalent CVD risk factor. Previous research findings indicate that various milk-derived peptides inhibit ACE activity in vitro and that fermented dairy foods (rich in bioactive peptides) significantly lowers blood pressure in vivo. However few clinical studies had been conducted to prove the efficacy of whey protein derived peptides to reduce blood pressure. A hydrolyzed whey protein ingredient containing bioactive whey peptides has been developed that has shown ACE-inhibiting activity in vitro and blood pressure lowering results in vivo in animal model studies. A clinical trial was designed to prove the blood pressure lowering effect of these peptides (20g/d) in generally healthy, non-medicated, borderline hypertensives. A well-designed double blind, randomized placebo controlled clinical study also allows for the analysis of other traditional and novel CVD risk factors including blood lipids, hs-CRP, insulin, as well as ACE activity, bradykinin, safety, side effects and mechanism. Compared to the control sBP, dBP, LDL-C and hs-CRP dropped significantly, and ACE activity and bradykinin increased significantly. Diet, activity levels and body weight as well as all safety measures and side effects were unchanged throughout the study. The clinical study proved that the whey peptides can significantly lower blood pressure in pre- and stage 1 hypertensives, likely by altering ACE activity and bradykinin levels, and appears to be a safe and well tolerated treatment for traditional as well as nontraditional CVD risk factors.

Session 30, Whey proteins in foods: Past, present and future
9:00 AM - 12:00 PM, Monday AM Room 392

2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana