A nutraceutical combination improves insulin sensitivity in patients with metabolic syndrome

Table 2 Summary of patient characteristics, primary and secondary endpoints

	AP			Placebo
	Baseline	18-wk	Within-group difference vs baseline (P)	Baseline	18-wk	Within-group difference vs baseline (P)	Δ from baseline AP	Δ from baseline placebo	Between-group comparison of Δ (P)
Number (M/F)	29 (20/9)			30 (18/12)
Age	53 ± 7			50 ± 11.9
Smoker	3/29			3/30
Weight (kg)	90 ± 13	88 ± 12	0.008	96 ± 18	95 ± 18	0.011	-1.6 ± 3.1	-1.3 ± 2.6	0.657
BMI (kg/m2)	32.2 ± 4.6	31.7 ± 4.4	0.013	34.7 ± 5.1	34.2 ± 5.1	0.008	-0.5 ± 1.1	-0.5 ± 0.9	0.805
Waist circumference (cm)	110 ± 9	107 ± 9	0.018	115 ± 13	114 ± 13	0.087	-2.4 ± 5.1	-1.2 ± 3.6	0.301
Systolic blood pressure (mmHg)	125 ± 13	120 ± 9	0.037	125 ± 14	126 ± 12	0.585	-5 ± 14	1 ± 12	0.047
Diastolic blood pressure (mmHg)	78 ± 8	75 ± 8	0.087	81 ± 8	78 ± 7	0.084	-3 ± 8	-3 ± 10	0.753
Fasting glucose (mmol/L)	5.72 ± 1.22	5.28 ± 1.11	0.006	4.72 ± 0.67	4.55 ± 0.67	0.006	-0.44 ± 0.78	-0.22 ± 0.39	0.186
Fasting Insulin (pmol/L)	90 ± 42	76 ± 42	0.165	90 ± 69	111 ± 90	0.119	-14 ± 35	21 ± 57	0.042
HOMA-IR	3.2 ± 1.5	2.6 ± 1.3	0.019	2.8 ± 2.2	3.2 ± 2.6	0.259	-0.6 ± 1.2	0.4 ± 1.9	0.023
Mean postprandial glucose (mmol/L)	7.00 ± 1.89	6.67 ± 1.61	0.085	5.89 ± 1.33	6.05 ± 0.89	0.309	-0.33 ± 1.00	0.16 ± 0.78	0.046
Mean postprandial Insulin (pmol/L)	306 ± 125	298 ± 159	0.793	409 ± 194	507 ± 347	0.017	-7 ± 115	100 ± 215	0.023
OGTT Glucose at 2 h (mmol/L)	8.89 ± 3.44	8.33 ± 3.00	0.216	6.94 ± 1.94	7.17 ± 1.89	0.478	-10 ± 47	4 ± 25	0.153
Triglycerides (mmol/L)	1.76 ± 0.86	1.73 ± 0.85	0.933	1.92 ± 0.83	2.07 ± 1.28	0.375	-0.01 ± 0.89	0.17 ± 1.03	0.467
Total cholesterol (mmol/L)	5.40 ± 1.00	4.60 ± 0.59	< 0.001	5.09 ± 1.03	5.08 ± 0.82	0.253	-0.82 ± 0.76	-0.13 ± 0.60	< 0.001
HDL cholesterol (mmol/L)	1.08 ± 0.26	1.08 ± 0.23	0.757	1.18 ± 0.35	1.1 ± 0.28	0.054	0.00 ± 0.13	-0.08 ± 0.21	0.074
LDL cholesterol (mmol/L)	3.49 ± 0.19	2.69 ± 0.54	< 0.001	3.05 ± 1	2.93 ± 0.99	0.200	-0.82 ± 0.68	-0.13 ± 0.55	< 0.001
Flow mediated dilation (%)	6.8 ± 3.1	8.7 ± 3.3	0.021	6.8 ± 1.9	6.8 ± 2.1	0.982	1.9 ± 4.2	0 ± 1.9	0.032

AP: Neutraceutical consisting of berberine, policosanol and red yeast rice; OGTT: Oral glucose tolerance test; HOMA-IR: Homeostasis model assessment of insulin resistance; BMI: Body mass index; HDL: High density lipoprotein; LDL: Low density lipoprotein.