A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure
Table 3
Changes in ambulatory SBP and DBP for all subjects in the ITT population during the 8-week supplementation period.
Ambulatory Measure
W 0
W 4
W 8
Change from W 0 to W
Change from W 0 to W
Within-group (p-value)
Between-group p-value
Within-group (p-value)
Between-group p-value
SBP (mmHg; mean ± SD)
24-hour Ambulatory
RPC
130.5 ± 10.3
130.2 ± 10.2
129.0 ± 9.6
-0.6 ± 11.5
0.015
-1.6 ± 9.0
0.006
(p=0.684)
(p=0.138)
Placebo
132.4 ± 11.2
135.0 ± 11.5
134.4 ± 11.7
+2.4 ± 10.1
+1.8 ± 11.4
(p=0.052)
(p=0.200)
Daytime Ambulatory
RPC
136.1 ± 10.6
135.1 ± 11.1
134.0 ± 11.5
-1.3 ± 12.2
0.014
-2.2 ± 9.3
0.002
(p=0.385)
(p=0.049)
Placebo
137.6 ± 12.7
140.4 ± 13.1
140.6 ± 12.9
+2.4 ± 12.4
+2.6 ± 13.9
(p=0.115)
(p=0.122)
Night-time Ambulatory
RPC
121.0 ± 11.8
120.4 ± 10.2
119.9 ± 9.5
-0.9 ± 14.8
0.007
-1.4 ± 13.9
0.166
(p=0.613)
(p=0.408)
Placebo
124.0 ± 12.1
125.7 ± 12.5
123.1 ± 12.6
+2.0 ± 11.8
-1.0 ± 13.5
(p=0.165)
(p=0.551)
DBP (mmHg; mean ± SD)
24-hour Ambulatory
RPC
80.1 ± 7.5
80.4 ± 8.3
80.1 ± 7.4
+0.1 ± 6.5
0.139
-0.1 ± 6.8
0.047
(p=0.864)
(p=0.916)
Placebo
80.8 ± 8.2
82.4 ± 8.6
82.9 ± 8.7
+1.5 ± 8.0
+2.0 ± 9.9
(p=0.106)
(p=0.096)
Daytime Ambulatory
RPC
84.8 ± 8.1
84.3 ± 8.8
84.0 ± 8.6
-0.7 ± 6.4
0.036
-0.9 ± 7.2
0.004
(p=0.367)
(p=0.294)
Placebo
85.1 ± 8.8
87.1 ± 9.5
88.2 ± 9.4
+1.8 ± 9.4
+2.9 ± 11.2
(p=0.115)
(p=0.034)
Night-time Ambulatory
RPC
72.8 ± 11.0
72.9 ± 8.6
73.2 ± 8.0
-0.2 ± 12.0
0.356
+0.1 ± 12.3
0.674
(p=0.914)
(p=0.930)
Placebo
74.0 ± 10.3
74.1 ± 8.8
73.8 ± 9.4
+0.3 ± 9.4
-0.1 ± 11.8
(p=0.766)
(p=0.920)
ANCOVA: analysis of covariance; DBP: diastolic blood pressure; ITT: Intention-to-treat; mmHg: millimeter of mercury; RPC: Refined Peptide Concentrate; SBP: systolic blood pressure; SD: standard deviation; W: week W 0, either 1 or 2 subjects per group had ambulatory blood pressure recording errors and thus data from 70 or 71 subjects per group were used to generate ambulatory SBP and DBP values for W 0. Although ambulatory SBP and DBP data were available for all 72 subjects per group at W 4 and W 8, due to the aforementioned reason, data from 70 or 71 subjects per group were used to calculate changes from W 0 to W 4 and W 0 to W 8. -group comparisons of the changes from W 0 to W 4 and W 0 to W 8 were made using the paired Student t-test. Between-group comparisons of the change from W 0 to W 4 and W 0 to W 8 were made using ANCOVA with the value at baseline used as the covariate. p≤0.05 was considered statistically significant.
