Mizuno Seiichi, Matsuura Keiichi, Gotou Takanobu, Nishimura Shingo, Kajimoto Osami, Yabune Mitsuharu, Kajimoto Yoshitaka, Yamamoto Naoyuki
Food Research Laboratory, Calpis Co. Ltd. Sagamihara, Kanagawa, Japan.
Br J Nutr. 2005 Jul;94(1):84-91. doi: 10.1079/bjn20051422.
We describe a clinical trial to study the efficacy of a casein hydrolysate, prepared using an Aspergillus oryzae protease, containing the major angiotensin-I-converting enzyme inhibitory peptides Val-Pro-Pro (VPP) and Ile-Pro-Pro (IPP) in a single-blind, placebo-controlled study. A total of 131 volunteers with high-normal blood pressure and mild hypertension were randomly divided into four groups (n 32 or 33 in each group). Each volunteer was given two tablets containing four different dosages of VPP and IPP (VPP+IPP: 0, 1.8, 2.5 and 3.6 mg), daily for 6 weeks. A significant decrease in systolic blood pressure was observed at 6 weeks in the active group receiving 1.8 mg (P<0.01) VPP and IPP; in the active groups receiving either 2.5 mg or 3.6 mg, systolic blood pressure was decreased at both 3 weeks (P<0.05 and P<0.05) and 6 weeks (P<0.001 and P<0.0001) compared with systolic blood pressure measured before treatment. Changes in the systolic blood pressure after 6 weeks of treatment in the four groups were --1.7, --6.3, --6.7 and --10.1 mmHg, and these effects were dose dependent. In addition, a significant difference in systolic blood pressure between the placebo group and the VPP and IPP group receiving 3.6 mg was observed (P<0.001) by two-way ANOVA. The antihypertensive effect was greater in mildly hypertensive subjects (n 20 or 21 in each group) than in any of the other subjects. No significant change of diastolic blood pressure was observed for all the test groups, and no differences in diastolic blood pressure in the test sample groups compared with the placebo group were observed during the test period.
我们描述了一项临床试验，在一项单盲、安慰剂对照研究中，研究使用米曲霉蛋白酶制备的酪蛋白水解物的疗效，该酪蛋白水解物含有主要的血管紧张素 I 转换酶抑制肽缬氨酸 - 脯氨酸 - 脯氨酸（VPP）和异亮氨酸 - 脯氨酸 - 脯氨酸（IPP）。共有 131 名血压高正常和轻度高血压志愿者被随机分为四组（每组 n = 32 或 33）。每位志愿者每天服用两片含有四种不同剂量 VPP 和 IPP（VPP + IPP：0、1.8、2.5 和 3.6 毫克）的片剂，持续 6 周。在接受 1.8 毫克（P < 0.01）VPP 和 IPP 的活性组中，6 周时观察到收缩压显著下降；在接受 2.5 毫克或 3.6 毫克的活性组中，与治疗前测量的收缩压相比，3 周时（P < 0.05 和 P < 0.05）和 6 周时（P < 0.001 和 P < 0.0001）收缩压均下降。治疗 6 周后四组收缩压的变化分别为 -1.7、-6.3、-6.7 和 -10.1 mmHg，且这些效应呈剂量依赖性。此外，通过双向方差分析观察到安慰剂组与接受 3.6 毫克 VPP 和 IPP 组之间的收缩压存在显著差异（P < 0.001）。轻度高血压受试者（每组 n = 20 或 21）的降压效果比其他任何受试者都更显著。所有测试组的舒张压均未观察到显著变化，并且在测试期间，测试样本组的舒张压与安慰剂组相比也未观察到差异。
