Effect of Ginger Powder Supplementation in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized Clinical Trial

Figures & data

Figure 1 Flow chart of the study.

Table 1 Baseline Characteristics in Two Groups

Variables	Ginger (n =23)	Placebo (n =23)	PV
Gender (male/female), %^a	43.5/56.5	43.5/56.5	1
Smoker, No.^a	2	2	1
Age, y^b	50.04 ± 10.26	47.95 ± 9.24	0.47
Height, cm^b	167.19±11.6	170.5±9.55	0.298
BMI (kg/m^2)^b	31.70±3.75	30.94±1.98	0.349

Notes: ^aData are tested by chi-square test. ^bData are expressed as mean± standard deviation and tested by independent samples t-test.

Table 2 Intra- and Inter-Group Comparisons of the Changes from Baseline to the End of the Intervention for Fatty Liver Status, Anthropometric and Nutritional Variables in Both Groups

Variables	Ginger (n =23)		PV ^c	Placebo (n =23)		PV^d	PV^e
	Baseline	End	PV ^c	Baseline	End
Weight (kg)^b	88.61 ± 11.50	86.34 ± 10.85	<0.001	89.74 ± 6.45	87.61 ± 6.05	< 0.001	0.773
BMI (kg/m^2)^b	31.78 ± 3.71	30.96 ± 3.41	<0.001	30.94 ± 1.98	30.22± 2.06	< 0.001	0.544
WC (cm)^b	105.15 ± 7.26	103.84 ± 7.25	<0.001	104.71± 8.21	103.86 ± 7.94	0.007	0.271
HC(cm)^b	106.41 ± 5.36	105.58 ± 5.36	0.009	105.82 ± 5.66	104.94 ± 5.45	0.005	0.897
WHR^b	0.98 ± 0.04	0.98 ± 0.05	0.168	0.98 ± 0.06	0.99 ± 0.06	0.953	0.529
PA^b (METmin/wee)	194.89±107.96	247.04± 98.79	0.008	174.32± 99.97	223.82± 81.87	0.020	0.959
Energy (kcal)^b	2033.26 ± 195	1945.65±243.92	<0.001	2123.73 ± 194.5	2003.56±178.08	< 0.001	0.235
Fat(gr)^b	29.35 ± 1.71	28.41±1.75	0.57	28.53 ± 1.76	28.10±2.07	0.26	0.402
Pro(gr)^b	12.83 ± 0.97	12.43±0.99	0.40	13.0 ± 0.99	12.83±0.84	0.43	0.423
Cho(gr)^b	57.85 ± 2.28	59.10±1.82	0.20	58.46 ± 2.06	59.06±1.88	0.15	0.316
Grade of NAFLD, %^a 0.328 0.328 1 I, (No.) 52.17(12) 56.52 (13) 52.17(12) 56.52(13) II, (No.) 34.78(8) 30.43(7) 34.78(8) 30.43(7) III, (No.) 13.04(3) 13.04(3) 13.04(3) 13.04(3)

Notes: ^aData are tested by McNemar test (within the groups) and chi-square test (between the groups). ^bData are expressed as mean ±standard deviation and tested by Paired t-test (within the groups) and independent samples t-test (between the groups) ^cChanges post-baseline in ginger group. ^dChanges post-baseline in placebo group. ^eChanges between groups.

Abbreviations: PA, Physical Activity; WC, Waist Circumference; WHR, Waist to Hip Ratio.

Table 3 Intra- and Inter-Group Comparisons of the Changes from Baseline to the End of the Intervention for Biochemical Parameters

Variables	Ginger (n =23)		PV^c	Placebo (n =23)		PV^d	PV^e
	Baseline	End		Baseline	End
Markers of insulin resistance
FBS(mg/dL)^a	107.52 ± 10.64	99.34 ± 12.57	0.007	106.13 ± 8.48	105.21 ± 8.68	0.603	0.029
Insulin (µU/mL)^a	13.38 ± 2.75	12.42 ± 2.53	0.017	13.72± 1.51	13.09± 1.66	0.159	0.559
HOMA-IR^a	3.72± 0.76	3.07 ± 0.80	0.001	3.74 ± 0.82	3.58 ± 0.79	0.314	0.047
Serum lipid parameters
TG (mg/dL)^a	200.60 ± 48.56	196.43 ± 46.24	0.503	203.86 ± 20.63	201.34 ± 29.13	0.537	0.823
Chol (mg/dL)^a	220.82±45.95	196.13±36.23	0.006	217.82±33.07	214.65±34.9	0.190	0.026
LDL-C (mg/dL)^a	136.59 ± 45.70	113.56± 37.90	0.010	134.91 ± 32.34	130.52 ± 33.32	0.074	0.032
HDL-C (mg/dL)^a	43.69 ± 7.43	44.73 ± 6.54	0.341	42.56 ± 8.39	43.52± 9.31	0.245	0.948
LDL-C/HDL-C^b	2.95(1.41,6.44)	2.41(1.29,8.17)	0.033	3.43(1.93,5.68)	3.05(1.68,7.63)	0.089	0.267
Liver enzymes markers
AST(IU/L)^a	32.69 ± 5.23	31.08 ± 7.85	0.312	32.13 ± 8.43	31.65 ± 7.86	0.712	0.561
ALT(IU/L)^a	42.04 ± 8.92	32.21 ± 7.12	<0.001	38.26 ± 6.21	34.95 ± 5.21	0.023	0.018
GGT (U/L)	41.21± 7.76	32.17± 7.76	<0.001	40.69± 7.07	36.78 ± 7.84	0.035	0.060
Blood pressure
SBP^a (mmHg)	128.21± 8.79	125.21± 11.72	0.204	131.52± 9.55	127.60 ± 9.27	0.117	0.804
DBP^a (mmHg)	79.17 ± 8.40	76.65 ± 9.83	0.063	81.04 ± 10.49	79.91 ± 9.8	0.458	0.845

Notes: ^aData are expressed as mean±standard deviation and tested by Paired t-test (within the groups) and independent samples t-test (between the groups). ^bData are expressed as median (minimum, maximum) and tested by Wilcoxon paired rank test (within the groups) and Mann–Whitney U-test (between the groups). ^cChanges post-baseline in ginger group. ^dChanges post-baseline in placebo group. ^eChanges between groups.

Abbreviations: ALT, Alanine Aminotransferase; AST, Aspartate Aminotransferase; GGT, Gamma-Glutamyltransferase; DBP, Diastolic blood pressure; FBS, Fasting Blood Sugar; HDL-C, High-Density Lipoprotein Cholesterol; HOMA-IR, Homeostatic Model Assessment of Insulin Resistance; LDL-C, Low-Density Lipoprotein Cholesterol; SBP, Systolic blood pressure, TC, Total Cholesterol; TG, Triglyceride.

Table 4 Intra- and Inter-Group Comparisons of the Changes from Baseline to the End of the Intervention for Biochemical Parameters

Variables	Ginger (n =23)			PV^c	Placebo (n =23)		PV^d	PV^e
	Baseline	End			Baseline	End
Antioxidant and Inflammatory Markers
TAC (mMol)^a	1.23± 0.20		1.31 ± 0.23	0.081	1.25 ± 0.26	1.27 ± 0.19	0.694	0.466
hs-CRP(mg/L)^b	2.40(1.14,3.58)		1.82(0.88,3.18)	0.001	2.26 (1.16,3.98)	2.12(0.98,3.78)	0.128	0.006
TNF-α(pg/mL)^a	11.71 ± 1.02		11.40 ± 1.70	0.309	11.63 ± 1.77	11.57 ± 1.23	0.880	0.496
adponectin^b	1.20(0.8,1.7)		1.3(0.9,1.6)	0.150	1.20(0.8,1.7	1.30(1,1.7)	0.161	0.959
Fetuin-A^a	262.39±30.21		228.21±39.26	0.001	256.47±38.14	256.82±36.79	0.967	0.008
FLI^b	89.43(52.5,97.3)		85.21(39.2,96)	< 0.001	86.35(68.8,94.4)	82.56(66.5,93.5)	< 0.001	0.116

Notes: ^aData are presented as mean±standard deviation. ^bData are presented as median. ^cChanges post-baseline in ginger group. ^dChanges post-baseline in placebo group. ^eChanges between groups.

Abbreviations: FLI, Fatty Liver Index; hsCRP, High-Sensitivity C-Reactive Protein; TAC, Total Antioxidant Capacity; TNF-α, Tumor Necrosis Factor-Alpha.