Milk-based dietary supplement produces significant results in two placebo-controlled trials .

Two new clinical trials presented by Calpis Co., Ltd. at the American Society of Hypertension (ASH) Twenty-Third Annual Scientific Meeting and Exposition (ASH 2008) show that the milk-derived dietary supplement AmealPeptide® reduces blood pressure in hypertensive patients. The studies, called AHEAD (Achieve Hypertension Efficacy with AmealPeptide® Dietary Supplement ) II, and the PROBE (A Prospective, Two-phase Randomized, Open-Label, Blinded End-Point) Dose Response Study confirmed the safety and efficacy of AmealPeptide® for patients with Stage I and Stage II hypertension.

AmealPeptide® is derived from the milk protein casein and consists of two tripeptides - Valine-Proline-Proline (VPP) and Isoleucine-Proline-Proline (IPP) - that have been shown to have characteristics of angiotensin converting enzyme (ACE) inhibitors . These peptide sequences exist naturally in casein. However, they are not released in the gut by the action of digestive enzymes. They are released by propriety fermentation and enzymatic processes developed by Calpis Co., Ltd.

The AHEAD II study found that the milk-based product produced a mean drop in daytime, ambulatory systolic blood pressure of 3.6 mmHg for the active group after 6 weeks of treatment. The change was both statistically and clinically significant. According to JNC 7 (The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure), just a 2 mmHg reduction in systolic blood pressure results in a 6% reduction in mortality due to stroke and a 4% reduction in mortality due to coronary heart disease (CHD).

Results of the PROBE study showed AmealPeptide® to have a dose dependent blood pressure lowering trend and a reduction of daytime ambulatory blood pressure of 7.6 mmHg (± 8.7) in the 75 mg a day group and also a significant reduction in 24-hr systolic blood pressure in the same group of 6.2 mmHg (± 8.4) from the baseline after 8 weeks of treatment. A lower dose of 5 mg a day of AmealPeptide® also showed blood pressure lowering effect.

“It’s very exciting to see blood pressure reductions achieved by the food derived substance, AmealPeptide®” stated Joel Neutel, MD, Associate Clinical Professor of Medicine at the University of California, Irvine and a specialist in clinical hypertension of the American Society of Hypertension. “With hypertension and prehypertension on the rise, physicians and patients need as many effective tools as possible for the management of this condition,” he concluded.

The AHEAD II study enrolled 81 newly diagnosed stage I and stage II hypertensives. All subjects had a mean daytime systolic blood pressure between 140 mmHg and 179 mmHg at the start of the trial. Fifty-two received 75 mg of AmealPeptide® twice a day for 6 weeks, while 29 received a placebo. The PROBE study enrolled 59 diagnosed stage I and stage II hypertensives who were not taking any antihypertensive medications or who were uncontrolled on antihypertensive therapy. All subjects had a mean seated systolic blood pressure between 150 mmHg and 179 mmHg and a mean daytime systolic blood pressure between 140 mmHg and 179 mmHg at the start of the trial. All enrolled received AmealPeptide® (5mg, 15mg, 50mg, 75mg a day or 75mg twice a day) or placebo.

"Calpis takes pride in conducting research that holds up under serious scientific scrutiny," said Craig Tillman, Vice President of Sales & Marketing, Calpis USA, Inc. "This new data confirms that AmealPeptide® can make a difference in those with elevated blood pressure."

The AHEAD II and PROBE data builds on more than 11 previous Japanese placebo-controlled clinical studies showing that AmealPeptide® lowers blood pressure in hypertensives and prehypertensives without producing the side effects that can be associated with drug therapy (Courtesy of EurekAlert!, a service of AAAS).