Calpis' AmealPeptide® Lowers Blood
Pressure in Two Placebo-Controlled Trials
Milk-based dietary supplement produces significant results in
hypertensive patients
NEW ORLEANS (Business Wire EON) May 16, 2008 --
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) in New Orleans 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.
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.
About AmealPeptide®
AmealPeptide® is derived from the milk
protein casein and consists of two tripeptides -- Valine-Proline-Proline
(VPP) and Isoleucine-Proline-Proline (IPP) -- that has been shown to
have angiotensin converting enzyme (ACE) inhibitory characteristics.
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.
About Calpis
Since 1917, Calpis Co., Ltd. has manufactured and sold fermented and
cultured milk-based products. Calpis' innovative microbiological
technology is in the forefront of scientific achievement in lactic-acid
fermentation processing, and has secured its leading position in the
global marketplace.
Calpis is the first and only company to isolate AmealPeptide®,
which has been shown to safely lower blood pressure in 13 published,
scientific clinical studies. It recently introduced ameal bp®,
a dietary supplement containing AmealPeptide®,
in the U.S. market. Calpis is well known in Asia as a soft drink brand,
and in recent years its AmealPeptide®-based
health drinks and dietary supplements have made their mark on the
burgeoning functional foods market in Japan, Europe and the U.S. For
more information visit www.calpis.net.
About ASH
The American Society of Hypertension, Inc. (ASH) is the largest US
organization devoted exclusively to hypertension and related
cardiovascular diseases. ASH is committed to alerting physicians, allied
health professionals and the public about new medical options, facts,
research findings and treatment choices designed to reduce the risk of
cardiovascular disease. For more information, visit www.ash-us.org.
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