|
Variables
|
Intervention
|
Baseline Mean(SD)
|
3 Months Mean(SD)
|
P-value$
|
Mean Difference (95% CI)
|
P-value#
|
|---|
|
Time
|
Treatment
|
Interaction
|
|---|
|
Weight (kg)
|
Nanocurcumin (n = 42)
|
86.5 (10.9)
|
83.7 (10.7)
|
< 0.001
|
−2.8 (−3.5, −2.0)
|
< 0.001
|
0.8
|
0.3
|
|
Placebo (n = 42)
|
86.7(11.0)
|
84.3(11.0)
|
< 0.001
|
−2.4 (−3.1, −1.6)
|
< 0. 1
|
0.3
|
0.3
|
|
BMI (kg/m2)*
|
Nanocurcumin (n = 42)
|
30.6(2.14)
|
29.7(2.10)
|
< 0.001
|
−0.9 (− 1.0, −0.7)
|
< 0.001
|
0.6
|
0.2
|
|
Placebo (n = 42)
|
30.7(2.35)
|
29.9(2.53)
|
< 0.001
|
− 0.8 (− 0.9, − 0.6)
|
0.03
|
0.9
|
0.3
|
|
Fat Mass (%)
|
Nanocurcumin (n = 42)
|
31.6(6.4)
|
30.3(6.5)
|
< 0.001
|
−1.3 (− 1.7, − 0.8)
|
< 0.001
|
0.7
|
0.3
|
|
Placebo (n = 42)
|
31.9(4.7)
|
30.7(4.9)
|
< 0.001
|
−1.2 (− 1.5, − 0.8)
|
0.003
|
0.1
|
0.9
|
|
Waist circumference (cm)
|
Nanocurcumin (n = 42)
|
105.4(6.2)
|
99.6(5.7)
|
< 0.001
|
−5.8 (−6.2, −5.3)
|
< 0.001
|
0.6
|
< 0.001
|
|
Placebo (n = 42)
|
103.8(6.7)
|
102.5(6.9)
|
< 0.001
|
−1.3 (− 1.7, − 0.8)
|
0.07
|
0.9
|
< 0.001
|
|
SBP (mmhg)
|
Nanocurcumin (n = 42)
|
120.3(4.7)
|
118.2(4.4)
|
0.008
|
−2.1 (−2.4, −1.7)
|
0.001
|
0.3
|
0.3
|
|
Placebo (n = 42)
|
120.7(4.3)
|
119.6(4.9)
|
0.07
|
−1.1 (−1.4, −0.7)
|
0.7
|
0.4
|
0.8
|
|
DBP (mmhg)
|
Nanocurcumin (n = 42)
|
78.8(4.5)
|
77.9(2.9)
|
0.102
|
−0.9 (−1.1, − 0.6)
|
0.008
|
0.2
|
0.7
|
|
Placebo (n = 42)
|
79.8(4.3)
|
78.7(3.4)
|
0.03
|
−1.1 (−1.3, 0.8)
|
0.4
|
0.4
|
0.7
|
|
ALT (u/l)**
|
Nanocurcumin (n = 42)
|
42.8(11.6)
|
32.6(9.9)
|
< 0.001
|
−10.2 (− 10.9, −9.4)
|
< 0.001
|
0.1
|
< 0.001
|
|
Placebo (n = 42)
|
42.1(8.2)
|
39.6(7.5)
|
0.001
|
−2.5 (−3.0, 1.9)
|
0.4
|
0.3
|
< 0.001
|
|
AST (u/l)^
|
Nanocurcumin (n = 42)
|
28.43(6.7)
|
22.03(5.9)
|
< 0.001
|
−6.4 (−6.8, −5.9)
|
< 0.001
|
0.3
|
< 0.001
|
|
Placebo (n = 42)
|
27.60(7.8)
|
25.63(7.2)
|
0.002
|
−1.97 (−2.47, − 1.46)
|
0.052
|
0.7
|
< 0.001
|
|
TC (mg/dl)
|
Nanocurcumin (n = 42)
|
212.9(18.9)
|
195.2(19.8)
|
< 0.001
|
−17.7 (− 19.0, − 16.3)
|
< 0.001
|
0.2
|
0.002
|
|
Placebo (n = 42)
|
211.8(21.8)
|
205.0(20.5)
|
0.005
|
−6.8 (−8.2, 5.3)
|
0.3
|
0.9
|
0.01
|
|
LDL-c (mg/dl)
|
Nanocurcumin (n = 42)
|
135.6(17.6)
|
114.6(20.5)
|
< 0.001
|
−21.0 (−22.2, −19.7)
|
< 0.001
|
0.3
|
< 0.001
|
|
Placebo (n = 42)
|
133.0(20.7)
|
125.7(22.2)
|
< 0.001
|
−7.3 (−8.7, −5.8)
|
0.01
|
0.9
|
0.003
|
|
TG (mg/dl)
|
Nanocurcumin (n = 42)
|
175.9(70.3)
|
142.5(49.9)
|
< 0.001
|
−33.4 (−37.5, −29.2)
|
< 0.001
|
0.1
|
< 0.001
|
|
Placebo (n = 42)
|
181.2(65.6)
|
175.3(62.5)
|
0.007
|
−5.9 (−10.2, −1.5)
|
0.5
|
0.057
|
0.001
|
|
HDL-c (mg/dl)
|
Nanocurcumin (n = 42)
|
41.8(5.6)
|
51.4(6.6)
|
< 0.001
|
9.6 (9.1, 10.0)
|
< 0.001
|
0.009
|
< 0.001
|
|
Placebo (n = 42)
|
42.7(5.7)
|
43.8(5.4)
|
0.001
|
1.1 (0.7, 1.4)
|
< 0.001
|
0.04
|
< 0.001
|
|
FBS (mg/dl)
|
Nanocurcumin (n = 42)
|
89.1(5.4)
|
86.3(5.2)
|
< 0.001
|
−2.8 (−3.1, −2.4)
|
< 0.001
|
0.3
|
< 0.001
|
|
Placebo (n = 42)
|
89.3(5.8)
|
88.2(5.5)
|
< 0.001
|
−1.1 (−1.4, 0.7)
|
0.6
|
0.2
|
0.03
|
|
HbA1c (%)
|
Nanocurcumin (n = 42)
|
5.2(0.218)
|
5.1(0.229)
|
< 0.001
|
−0.1 (−0.115, −0.085)
|
< 0.001
|
0.1
|
0.001
|
|
Placebo (n = 42)
|
5.3(0.218)
|
5.2(0.188)
|
< 0.001
|
−0.1 (− 0.114, − 0.086)
|
0.01
|
0.8
|
0.002
|
|
Nesfatin (ng/ml)
|
Nanocurcumin (n = 42)
|
1.81(0.54)
|
3.37(8.8)
|
< 0.001
|
1.56 (1.52, 1.59)
|
< 0.001
|
< 0.001
|
< 0.001
|
|
Placebo (n = 42)
|
1.88(0.49)
|
2.06(7.6)
|
< 0.001
|
.18 (0.14, 0.21)
|
< 0.001
|
0.003
|
< 0.001
|
|
FBI (μIU/ml)
|
Nanocurcumin (n = 42)
|
8.0(0.5)
|
6.5(0.9)
|
< 0.001
|
−1.5 (−1.54, −1.45)
|
< 0.001
|
0.001
|
< 0.001
|
|
Placebo (n = 42)
|
7.9(0.6)
|
7.6(0.7)
|
< 0.001
|
−0.3 (−0.34, −0.25)
|
0.3
|
0.08
|
< 0.001
|
|
TNF-α (ng/l)
|
Nanocurcumin (n = 42)
|
14.7(3.3)
|
7.3(2.9)
|
< 0.001
|
−7.4 (−7.5, −7.2)
|
< 0.001
|
< 0.001
|
< 0.001
|
|
Placebo (n = 42)
|
15.1(2.7)
|
13.7(4.0)
|
< 0.001
|
1.4 (−1.63, −1.16)
|
0.002
|
< 0.001
|
< 0.001
|
|
IL-6 (ng/l)
|
Nanocurcumin (n = 42)
|
7.60(1.56)
|
3.81(1.63)
|
< 0.001
|
−3.79 (−3.88, −3.69)
|
< 0.001
|
< 0.001
|
< 0.001
|
|
Placebo (n = 42)
|
7.99(1.52)
|
7.02(7.6)
|
< 0.001
|
−0.97 (−1.07, −0.86)
|
< 0.001
|
< 0.001
|
< 0.001
|
|
hs-CRP (mg/l)
|
Nanocurcumin (n = 42)
|
5.9(2.57)
|
3.6(1.58)
|
< 0.001
|
−2.3 (−2.44, −2.15)
|
< 0.001
|
0.3
|
< 0.001
|
|
Placebo (n = 42)
|
5.3(2.50)
|
5.2(2.47)
|
< 0.001
|
0.1 (−0.26, 0.06)
|
< 0.001
|
0.3
|
< 0.001
|
|
HOMA-IR (score)
|
Nanocurcumin (n = 42)
|
1.77(0.16)
|
1.39(0.21)
|
< 0.001
|
−0.38 (− 0.39, − 0.36)
|
< 0.001
|
0.001
|
< 0.001
|
|
Placebo (n = 42)
|
1.75(0.17)
|
1.65(0.18)
|
< 0.001
|
0.1 (−0.11, − 0.08)
|
0.3
|
0.04
|
< 0.001
|
|
QUICKI (score)
|
Nanocurcumin (n = 42)
|
0.3505(0.0049)
|
0.3643(0.0092)
|
< 0.001
|
0.0138 0.0143, 0.0133)
|
< 0.001
|
0.001
|
< 0.001
|
|
Placebo (n = 42)
|
0.3509(0.0057)
|
0.3543(0.0068)
|
< 0.001
|
0.0034 (0.0038, 0.0029)
|
0.3
|
0.3
|
< 0.001
|
- *Inversely transformed; **Transformed by square root; ^Logarithmically transformed; $Paired t-test; #Two way repeated measures-ANOVA (TWRM-ANOVA), top row: unadjusted; bottom row: adjusted for energy, total fat, saturated fat, monounsaturated fatty acid, vitamins D, B1, B6, and folate. ALT alanine transaminase, AST aspartate transaminase, BMI body mass index, FBI fasting blood insulin,FBS fasting blood sugar, HOMA-IR homeostasis model assessment-insulin resistance, hs-CRP: high-sensitive C-reactive protein, HDL-C: high density lipoprotein-cholesterol, IL-6: interleukin-6, LDL-C: low density lipoprotein-cholesterol, QUICKI: quantitative insulin sensitivity check index, TC: total cholesterol, TNF-α: tumor necrosis factor-alpha
