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Table 3 Baseline and follow-up clinical characteristics of participants according to the treatments (intention to treat analysis)

From: A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease

Variables

Placebo (n = 65)

Nutraceutical (n = 62)

p-value (unpaired t test between basal values)

Basal

Follow-up

p-value (paired t test)

Basal

Follow-up

p-value (paired t test)

Weight (kg)

80 ± 11

79 ± 11

0.011

77 ± 12

76 ± 11

< 0.001

0.26

BMI (kg/m2)

29.5 ± 3

29.1 ± 4

0.006

28.4 ± 4

28.0 ± 4

< 0.001

0.11

WHR

0.96 ± 0.07

0.95 ± 0.07

< 0.001

0.96 ± 0.07

0.93 ± 0.06

< 0.001

0.62

FM (kg)

25 ± 7

25 ± 7

0.81

24 ± 7

24 ± 7

0.49

0.30

SBP (mmHg)

118 ± 12

118 ± 10

0.90

118 ± 13

117 ± 13

0.78

0.92

DBP (mmHg)

76 ± 9

76 ± 9

0.55

76 ± 9

74 ± 9

0.012

0.91

CAP score (dB/m)

302 ± 32

277 ± 42

< 0.001

294 ± 32

265 ± 40

< 0.001

0.16

aCAP scorea (dB/m)

303 ± 4

–

–

292 ± 4

–

–

0.055

Stiffness (kPa)

4.6 ± 1.2

4.7 ± 1.1

0.34

4.7 ± 1.0

4.6 ± 1.1

0.24

0.53

Glucose (mg/dL)

89 ± 9

90 ± 9

0.17

91 ± 10

91 ± 9

0.41

0.14

Insulin (mU/L)

13 ± 10

12 ± 7

0.26

12 ± 7

11 ± 5

0.023

0.44

HOMA-IR

3.0 ± 2.3

2.8 ± 1.7

0.36

2.8 ± 1.7

2.4 ± 1.3

0.023

0.64

TC (mg/dL)

191 ± 32

192 ± 31

0.49

204 ± 31

210 ± 39

0.13

0.015

TG (mg/dL)

115 ± 49

121 ± 57

0.31

142 ± 86

133 ± 92

0.29

0.034

HDL-C (mg/dL)

49 ± 11

52 ± 12

0.001

50 ± 11

52 ± 12

0.009

0.66

Albumin (g/dL)

4.4 ± 0.3

4.5 ± 0.4

0.20

4.4 ± 0.5

4.5 ± 0.4

0.27

0.50

AST (IU/L)

22 ± 12

20 ± 10

0.09

22 ± 8

21 ± 6

0.40

0.77

ALT (IU/L)

25 ± 24

24 ± 18

0.57

24 ± 15

24 ± 13

0.84

0.73

γGT (UI/L)

27 ± 20

24 ± 17

0.020

24 ± 15

25 ± 15

0.50

0.37

Creatinine (mg/dL)

0.85 ± 0.1

0.87 ± 0.1

0.046

0.83 ± 0.2

0.83 ± 0.2

0.74

0.45

CRP (mg/L)

3.7 ± 1.6

3.6 ± 1.2

0.55

4.2 ± 3.6

3.8 ± 1.9

0.36

0.34

BAP (μmol/L)

1998 ± 540

2169 ± 385

0.12

1590 ± 427

1707 ± 506

0.031

< 0.001

Cytokine evaluation

 IL-1β (pg/mL)

16.6 ± 5

14.7 ± 11

< 0.001

15.9 ± 3

13.8 ± 3

0.002

0.65

 IL-6 (pg/mL)

9.2 ± 7

6.9 ± 1

< 0.001

8.1 ± 2

6.9 ± 1

< 0.001

0.75

 TNF-α (pg/mL)

12.9 ± 9

13.1 ± 9

0.93

15.5 ± 24

12.1 ± 5

0.93

0.94

  1. Difference between means by unpaired samples t test; within group variation by paired Student’s t test (two tailed); differences in BAP, IL-1β, IL-6 and TNF α by Mann–Whitney U test and Wilcoxon signed-rank test. Difference between means by unpaired samples t test with adjustment by General Linear Model
  2. BMI body mass index, WHR waist to hip ratio, FM fat mass, SBP systolic blood pressure, DBP diastolic blood pressure, CAP controlled attenuation parameter, HOMA-IR homeostatic model assessment of insulin resistance, TC total cholesterol, TG triglycerides, HDL-C high density lipoprotein cholesterol, AST aspartate aminotransferase, ALT alanine aminotransferase, γGT gamma glutamyltransferase, BAP biological antioxidant potential, IL-1β interleukin-1β, IL-6 interleukin-6, TNF-α tumor necrosis factor α
  3. aaCAP score adjusted for serum triglycerides at baseline
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Journal of Translational Medicine

ISSN: 1479-5876

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