A randomized double-blind placebo-controlled study was conducted on 63 subjects to determine the antihypertensive effect of a vegetable drink in which sardine protein hydrolysates containing a dipeptide, Valyl-Tyrosine (VY), were incorporated. The subjects, consisting of people with mild hypertension, high-normal blood pressure and normal blood pressure, were randomly divided into test (male/female = 25/6, average age 50.1 +/- 10.4 years old) and control groups (26/6, 49.0 +/- 5.0). Each subject in the test group was given 195 g of the vegetable drink containing 0.5 g of sardine peptides (sardine protein hydrolysates) with 0.4 mg of VY (test drink) once a day for 13 weeks in a row, and subjects in the control group were given the same amount of the vegetable drink without sardine peptides (control drink) in the same manner. In the test group, 40 subjects with mild hypertension or high-normal blood pressure (130 mmHg < or = systolic blood pressure (SBP) < 160 mmHg and/or 80 mmHg < or = diastolic blood pressure (DBP) < 100 mmHg) showed a significant decrease in SBP, from 142.0 +/- 10.3 mmHg at the start of the test to 134.4 +/- 11.1 mmHg during the first week of the test period, after which similar values were seen throughout the test period (13 weeks). Compared to the control group, the difference in SBP from baseline was statistically significant in the test group throughout the intake period. DBP also decreased significantly from 88.0 +/- 7.9 mmHg at baseline to 83.5 +/- 8.6 mmHg after 13 weeks. In the control group, SBP and DBP were 140.8 +/- 8.4 mmHg and 90.5 +/- 6.6 mmHg respectively at the start of the test, and neither decreased during the test period. In subjects with normal blood pressure, neither those in the test group nor those in the control group showed a significant change in SBP and DBP during the test period. An excessive ingestion test was performed on 25 subjects with hypertension, mild hypertension, high-normal blood pressure, and normal blood pressure by giving 585 g (3 times the recommended amount of intake) of the test drink for 14 days in a row. As a result, a significant decrease of blood pressure was observed in the hypertension, mild hypertension and high-normal blood pressure groups, but no excessive decline in blood pressure or any side-effects were associated with any subjects during the test period. In the groups with normal blood pressure, the excessive ingestion of the test drink did not affect blood pressure. In these two studies, physical check-ups and biochemical analyses of blood and urine were also conducted in all subjects, and no abnormalities were observed. These results suggest that the test drink containing sardine protein hydrolysates exhibited the antihypertensive effect in only the subjects with mild hypertension or high-normal blood pressure. No adverse effects were observed in either hypertensive or normotensive subjects.