|
Placebo
|
Nutraceutical
|
Difference of changes between arms
|
---|
Baseline
|
12 weeks
|
Baseline
|
12 weeks
|
P-value
|
---|
Weight (kg)
|
65 (64, 79)
|
66 (63, 80)
|
63 (59, 75)
|
64 (58, 74)
|
0.57
|
BMI (kg/m2)
|
24 (21, 27)
|
24 (21, 27)
|
24 (22, 27)
|
24 (22, 27)
|
0.72
|
WC (cm)
|
88 (84, 94)
|
87 (82, 91)
|
86 (83, 94)
|
91 (82, 96)
|
0.74
|
BIA (%)
|
31 (26, 41)
|
31 (27, 40)
|
32 (27, 37)
|
30 (26, 38)
|
0.12
|
VFR (%)
|
10 (7, 12)
|
11 (8, 13)
|
11 (8, 12)
|
11 (8, 12)
|
0.83
|
SBP (mmHg)
|
125 (110, 130)
|
120 (110, 128)
|
120 (120, 130)
|
120 (115, 130)
|
0.95
|
DBP (mmHg)
|
80 (80, 80)
|
80 (70, 80)
|
80 (80, 80)
|
80 (80, 83)
|
0.46
|
HR (bpm)
|
65 (64, 68)
|
64 (60, 67)
|
64 (60, 68)
|
65 (62, 71)
|
0.23
|
TC (mg/mL)
|
271 (256, 289)
|
267 (259, 293)
|
271 (239, 285)
|
208 (201, 263)
|
<.0001
|
LDL-C (mg/mL)
|
189 (174, 198)
|
183 (171, 202)
|
177 (167, 193)
|
136.5 (118, 151.5)
|
<.0001
|
HDL-C (mg/mL)
|
56 (48, 65)
|
58.5 (50, 68)
|
71 (43, 81)
|
71 (48, 88)
|
0.97
|
Non-HDL-C (mg/mL)
|
215 (198, 232)
|
217 (199, 232)
|
206 (189, 214)
|
198 (182, 208)
|
<.0001
|
TG (mg/mL)
|
113 (94, 127)
|
112 (99, 148)
|
127 (93, 156)
|
106 (80, 124)
|
0.66
|
apoAI (mg/dL)
|
113.5 (97.5, 126.5)
|
110 (94.5, 120)
|
128 (93, 139)
|
128 (100, 151)
|
0.24
|
apoB (mg/dL)
|
143.5 (134, 148)
|
135 (133, 151)
|
155 (137, 158)
|
118 (112, 131)
|
0.003
|
oxLDL (U/L)
|
71.2 (66.7, 84.0)
|
76.4 (71.1, 99.5)
|
78.3 (74.6, 129.0)
|
81.0 (64.5, 114.1)
|
0.014
|
Lp(a) (mg/dL)
|
4.5 (2, 15.5)
|
4 (2, 17.5)
|
7 (4.5, 12)
|
9 (4, 14.5)
|
0.20
|
PCSK9 (ng/dL)
|
341 (294, 375)
|
324 (259, 360)
|
341 (294, 375)
|
346 (302, 366)
|
0.38
|
FPG (mg/dL)
|
95 (90, 97)
|
93 (87, 101)
|
93 (89, 101)
|
95 (92, 103)
|
0.20
|
Insulin (mUI/L)
|
3.23 (2.64, 5.24)
|
3.04 (2.31, 6.51)
|
3.38 (2.24, 4.92)
|
3.01 (2.38, 5.12)
|
0.78
|
HOMA-IR
|
0.73 (0.59, 1.23)
|
0.69 (0.51, 1.64)
|
0.77 (0.52, 1.15)
|
0.77 (0.49, 1.24)
|
0.92
|
FGF19 (pg/mL)
|
233 (166, 337)
|
261 (164, 305)
|
218 (177, 299)
|
221 (183, 374)
|
0.98
|
FGF21 (pg/mL)
|
185 (72, 227)
|
148 (77, 263)
|
179 (158, 364)
|
161 (66, 309)
|
0.11
|
- Data are shown as median (1st quartile, 3rd quartile)
- Statistically significant P-values are indicated in bold
- BMI body mass index, WC waist circumference, BIA bioelectrical impedance analysis, VFR visceral fat rating, SBP Systolic blood pressure, DBP diastolic blood pressure, HR heart rate, TC total cholesterol, LDL-C low-density lipoprotein cholesterol, HDL-C high-density lipoprotein cholesterol, TG triglycerides, apoA-I apolipoprotein A-I, apoB apolipoprotein B, oxLDL oxidize LDL, Lp(a) lipoprotein (a), PCSK9 proprotein convertase subtilisin/kexin type 9, FPG fasting plasma glucose, sICAM-1 soluble intercellular adhesion molecular 1, HOMA-IR Homeostatic Model Assessment of Insulin Resistance, FGF fibroblast growth factor