Skip to main content

Table 2 Summary of primary and secondary end points

From: Nutraceutical approach for the management of cardiovascular risk – a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study

  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
  1. Data are shown as median (1st quartile, 3rd quartile)
  2. Statistically significant P-values are indicated in bold
  3. 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