Variable Statistic

Active Product(N = 12)

Placebo (N = 12)

 P-value

Total Subjects (N = 24)

 Reference Range
Age
years

Mean ± SD
Median (Min-Max)

41.9 ± 6.3
43.5 (30.0 – 55.0)

42.2 ± 7.3
43.0 (30.0 – 55.0)

 0.9162

42.0 ± 6.7
43.5 (30.0 – 55.0)

 30 - 65
Height
cm

Mean ± SD
Median (Min-Max)

176.5 ± 7.0
176.5 (166.0 – 188.0)

175.3 ± 6.6
174.5 (165.0 – 190.0)

 0.6511

175.9 ± 6.7
175.0 (165.0 – 190.0)

  
Weight
kg

Mean ± SD
Median (Min-Max)

91.9 ± 13.1
90.8 (73.6 – 117.3)

93.8 ± 17.1
95.5 (65.4 – 126.0)

 0.7903

92.9 ± 14.9
92.4 (65.4 – 126.0)

  
Body Mass Index (BMI)
kg/m2

Mean ± SD
Median (Min-Max)

29.5 ± 3.86
30.1 (24.2 – 34.3)

30.4 ± 4.0
31.2 (22.4 – 34.9)

 0.6609

30.0 ± 3.9
31.0 (22.4 – 34.9)

 18.00 to 34.99
Systolic BP
mm Hg

Mean ± SD
Median (Min-Max)

127.9 ± 12.2
126.5 (109.0 – 148.0)

123.4 ± 11.0
124.5 (106.0 – 140.0)

 0.3500

125.7 ± 11.6
124.5 (106.0 – 148.0)

  
Diastolic BP
mm Hg

Mean ± SD
Median (Min-Max)

82.8 ± 4.0
84.0 (76.0 – 89.0)

81.4 ± 8.1
81.5 (65.0 –90.0)

 0.5848

82.1 ± 6.3
83.0 (65.0 –90.0)

  
Heart Rate
beats/minute

Mean ± SD
Median (Min-Max)

73.1 ± 14.6
72.5 (52.0 – 102.0)

72.6 ± 12.3
71.5 (50.0 – 99.0)

 0.9369

72.8 ± 13.2
72.0 (50.0 – 102.0)

  
Hemoglobin (Hgb)
g/dL

Mean ± SD
Median (Min-Max)

15.6 ± 0.77
15.6 (14.3 – 16.7)

15.2 ± 1.2
15.3 (13.2 – 16.8)

 0.2438

15.4 ± 1.0
15.5 (13.2 – 16.8)

 (≥19y) 13.2-17.1
Hematocrit (Hct)
%

Mean ± SD
Median (Min-Max)

46.4 ± 2.0
46.4 (43.0 – 50.2)

45.2 ± 3.0
45.6 (39.2 – 49.5)

 0.1964

45.8 ± 2.6
45.9 (39.2 – 50.2)

 (≥19y) 38.5-50.0
White Cell Count (WBC)
Thousand/mm3

Mean ± SD
Median (Min-Max)

6.7 ± 1.5
7.2 (3.5 – 8.4)

8.0 ± 1.7
7.5 (5.8 – 12.2)

 0.0626

7.3 ± 1.7
7.5 (3.5 – 12.2)

 (≥19y) 3.8-10.8
Red Cell Count (RBC)
Million/mm3

Mean ± SD
Median (Min-Max)

5.2 ± 0.3
5.1 (4.8 – 5.7)

5.5 ± 1.3
5.2 (4.5 – 9.4)

 0.4310

5.4 ± 0.9
5.2 (4.5 – 9.4)

 (≥19y) 4.2-5.8
BUN
mg/dL

Mean ± SD
Median (Min-Max)

15.1 ± 4.6
15.5 (7.0 – 23.0)

12.2 ± 4.6
13.0 (1.5 – 21.0)

 0.1677

13.6 ± 4.8
14.0 (1.5 – 23.0)

 7.0 – 18.0
Creatinine
mg/dL

Mean ± SD
Median (Min-Max)

1.0 ± 0.1
1.0 (0.9 – 1.2)

1.0 ± 0.1
1.0 (0.8 – 1.3)

 0.9048

1.0 ± 0.1
1.0 (0.8 – 1.3)

 0.70 – 1.30
Alk Phos
U/L

Mean ± SD
Median (Min-Max)

63.7 ± 11.3
65.0 (36.0 – 82.0)

66.8 ± 14.1
66.0 (41.0 – 89.0)

 0.5738

65.3 ± 12.6
65.0 (36.0 – 89.0)

 45 - 117
ALT
U/L

Mean ± SD
Median (Min-Max)

34.0 ± 13.9
31.0 (18.0 – 69.0)

37.3 ± 17.7
29.5 (18.0 – 72.0)

 0.5600

35.6 ± 15.7
29.5 (18.0 – 72.0

 13 - 61
AST
U/L

Mean ± SD
Median (Min-Max)

23.3 ± 8.6
22.0 (8.0 – 42.0)

20.8 ± 5.8
20.5 (13.0 – 29.0)

 0.4491

22.0 ± 7.3
22.0 (8.0 – 42.0)

 15 - 37
Glucose
mg/dL

Mean ± SD
Median (Min-Max)

87.1 ± 6.2
86.0 (79.0 – 100.0)

86.3 ± 5.5
86.0 (79.0 – 98.0)

 0.7160

86.7 ± 5.7
86.0 (79.0 – 100.0)

 74 - 106

Table 1: Baseline Characteristics of Subjects in the Safety Population
Time Point Gherkin extract (pounds) Placebo (pounds) P-Value
Visit 2

1821.45±942.81
1440.00 (411.00–3124.00)

2262.17±1027.59
1908.00 (1595.00–5175.00)

 0.2956
Visit 3

2575.00±1056.39
2550.00 (959.00 – 3900.00)

2383.75±1103.48
2397.50 (580.00 – 4350.00)

 0.6755
Change from Visit 3 to Visit 2

753.55±845.74
600 (-340.00–2600)
p=0.0144

121.58±922.36
62.50 (-1265.00–1740.00)
p=0.6568

 0.1012

Table 2: Mean Plot for Total Workload