Table 2 Change in primary and secondary outcomes from baseline to 12 weeks after enrollment using a protocol analysis

Liver Fibrotouch

 FAP (dB/m)

Baseline

299.88 ± 20.80

301.56 ± 22.72

16.07 (8.90–23.25)

< 0.001

12 weeks

267.24 ± 25.56^b

284.39 ± 27.31^b

 LSM (kPa)

Baseline

6.74 ± 1.98

6.56 ± 1.62

-0.20 (-0.19-0.59)

0.317

12 weeks

5.58 ± 1.22^b

5.79 ± 1.42^b

Anthropometry

 BMI (kg/m²)

Baseline

29.37 ± 2.59

29.23 ± 2.65

1.46 (1.09–1.82)

< 0.001

12 weeks

26.69 ± 2.41^b

28.01 ± 2.76^b

Body composition

 Body fat mass (kg)

Baseline

29.29 ± 5.99

28.73 ± 6.43

3.33 (2.48–4.19)

<0.001

12 weeks

23.01 ± 5.61^b

25.70 ± 6.25^b

 Muscle mass (kg)

Baseline

51.09 ± 8.12

50.84 ± 9.54

0.97 (0.26–1.68)

0.008

12 weeks

49.75 ± 7.89^b

50.40 ± 8.85^b

 Skeletal muscle mass (kg)

Baseline

30.30 ± 5.25

30.30 ± 5.93

0.45(0.12–0.78)

0.007

12 weeks

29.49 ± 5.11^b

29.88 ± 5.66

Blood pressure monitoring

 SBP (mmHg)

Baseline

126.99 ± 12.88

123.03 ± 11.80

3.41 (0.81-6.00)

0.011

12 weeks

119.16 ± 9.86^b

120.45 ± 11.5^b

 DBP (mmHg)

Baseline

80.84 ± 9.77

78.39 ± 8.06

2.83 (0.77–4.90)

0.008

12 weeks

75.49 ± 7.37^b

76.98 ± 8.93

Liver function test

 ALT (U/L)

Baseline

43.43 ± 26.59

39.87 ± 23.20

4.06 (1.12–7.01)

0.007

12 weeks

21.66 ± 10.07^b

24.56 ± 11.11^b

 AST (U/L)

Baseline

28.44 ± 11.18

26.47 ± 9.69

2.20 (0.21–4.22)

0.030

12 weeks

20.05 ± 6.09^b

21.82 ± 7.74^b

 GGT (U/L)

Baseline

39.03 ± 21.44

36.59 ± 19.18

7.82 (5.17–10.47)

<0.001

12 weeks

20.76 ± 11.87^b

26.69 ± 11.45^b

Glucose metabolism biomarkers

 FPG (mmol/L)

Baseline

5.25 ± 0.55

5.29 ± 0.50

0.09 (-0.05-0.20)

0.209

12 weeks

5.10 ± 0.51^b

5.21 ± 0.50

 FINS (mIU/L)

Baseline

12.68 ± 6.37

13.19 ± 6.13

1.98 (0.87–3.10)

0.001

12 weeks

8.25 ± 3.84^b

10.25 ± 4.41^b

 HbA1c (%)

Baseline

5.56 ± 0.39

5.54 ± 0.36

0.15 (0.07–0.23)

< 0.001

12 weeks

5.35 ± 0.37^b

5.50 ± 0.35

 HOMA-IR

Baseline

3.02 ± 1.65

3.19 ± 1.67

0.45 (0.16–0.73)

0.003

12 weeks

1.92 ± 0.97^b

2.39 ± 1.10^b

 HOMA-β

Baseline

147.46 ± 76.22

158.69 ± 82.45

24.12 (9.72–38.50)

0.001

12 weeks

104.52 ± 46.42^b

129.55 ± 62.50^b

Lipid panel screen

 TC (mmol/l)

Baseline

4.91 ± 0.90

4.89 ± 0.76

0.09 (-0.26-0.09)

0.330

12 weeks

4.85 ± 0.88

4.71 ± 0.75^b

 LDL-C (mmol/L)

Baseline

3.04 ± 0.72

3.04 ± 0.70

0.03 (-0.17-0.12)

0.725

12 weeks

2.98 ± 0.69

2.96 ± 0.67

 HDL-C (mmol/L)

Baseline

1.18 ± 0.27

1.16 ± 0.22

0.03 (-0.08-0.21)

0.239

12 weeks

1.22 ± 0.24

1.18 ± 0.24

 TG (mmol/L)

Baseline

2.04 ± 1.02

1.94 ± 1.01

0.27 (0.11–0.42)

0.001

12 weeks

1.17 ± 0.59^b

1.39 ± 0.62^b

 Hcy (µmol/L)

Baseline

11.85 ± 4.77

11.47 ± 4.23

0.98 (0.29–1.66)

0.006

12 weeks

10.00 ± 3.06^b

10.46 ± 2.27