Table 1 Baseline characteristics and safety parameters.

From: Treatment with Anaerobutyricum soehngenii: a pilot study of safety and dose–response effects on glucose metabolism in human subjects with metabolic syndrome

 

All subjects

n = 24

p

105 cells/ml

n = 8

p

107 cells/ml

n = 8

p

109 cells/ml

n = 8

p

p*

p**

Week 0

Week 4

Week 0

Week 4

Week 0

Week 4

Week 0

Week 4

Age, years

54 [46–69]

  

60 [52–68]

  

47 [43–60]

  

56 [43–59]

  

0.078

 

Weight, kg

103 [92–111]

103 [91–111]

0.749

99 [87–110]

99 [87–108]

0.092

110 [99–117]

110 [99–118]

0.672

98 [87–109]

99 [88–110]

0.161

0.339

0.065

BMI, kg/m2

33 [30–33]

32 [30–33]

0.750

32 [29–34]

31 [29–34]

0.237

33 [31–33]

32 [31–33]

0.779

31 [29–34]

31 [29–34]

0.069

0.555

0.064

Waist circumference, cm

112 [107–118]

113 [106–117]

0.850

110 [105–114]

110 [105–115]

0.850

116 [109–118]

116 [111–117]

0.850

110 [104–120]

110 [104–120]

0.773

0.354

0.913

Fasting glucose, mmol/l

5.6 [5.2–5.8]

5.4 [5.2–5.6]

0.280

5.6 [5.2–5.9]

5.4 [4.9–5.8]

0.235

5.5 [5.1–5.9]

5.4 [5.2–5.9]

0.863

5.4 [5.2–5.9]

5.4 [5.1–5.6]

0.497

0.868

0.763

Insulin, pmol/l

85 [60–143]

97 [62–147]

0.668

86 [60–139]

79 [52–141]

0.484

98 [78–168]

126 [71–163]

0.327

79 [40–186]

102 [47–132]

0.292

0.907

0.309

HOMA-IR

3.1 [2.1–5.2]

3.4 [2.1–4.7]

0.689

3.3 [2.0–5.3]

2.4 [1.9–4.7]

0.401

3.4 [2.5–5.9]

4.2 [2.4–5.8]

0.093

2.9 [1.4–7.0]

3.4 [1.7–4.6]

0.233

0.912

0.172

Cholesterol

Total, mmol/l

5.7 [4.8–6.4]

5.7 [4.7–6.4]

0.764

5.9 [4.1–6.4]

5.5 [4.2–6.7]

0.889

5.6 [4.5–6.1]

5.8 [4.3–6.3]

0.889

5.7 [4.9–7.2]

5.7 [4.9–6.4]

0.888

0.505

0.987

LDL, mmol/l

3.9 [3.0–4.2]

3.8 [2.8–4.2]

0.370

3.8 [2.7–4.1]

3.7 [2.5–4.6]

1.000

3.5 [2.8–4.2]

3.7 [2.6–4.1]

0.484

4.0 [3.4–5.0]

3.8 [3.3–4.4]

0.327

0.430

0.777

HDL, mmol/l

1.0 [0.9–1.2]

1.0 [0.9–1.1]

0.931

1.1 [0.8–1.2]

1.1 [0.8–1.2]

0.866

0.9 [0.9–1.1]

0.9 [0.9–1.1]

0.351

1.1 [0.9–1.3]

1.0 [0.9–1.2]

0.236

0.378

0.304

Triglycerides, mmol/l

1.7 [1.4–1.8]

1.8 [1.4–2.4]

0.493

1.6 [1.4–2.5]

1.7 [1.3–1.9]

0.575

1.7 [1.4–2.3]

2.2 [1.2–2.5]

0.779

1.6 [1.3–1.9]

1.9 [1.2–2.7]

0.161

0.854

0.658

Systolic blood pressure, mmHg

140 [130–148]

138 [131–144]

0.082

144 [127–161]

141 [129–159]

0.609

142 [130–156]

141 [135–150]

0.482

137 [124–144]

134 [114–139]

0.028

0.578

0.058

Diastolic blood pressure, mmHg

92 [86–95]

85 [80–90]

0.002

90 [79–99]

85 [79–93]

0.237

95 [87–98]

88 [74–94]

0.069

89 [85–94]

83 [76–89]

0.012

0.390

0.581

Creatinine, µmol/l

87 [79–93]

84 [78–91]

0.236

88 [81–93]

85 [78–94]

0.172

89 [73–96

85 [77–91]

0.482

85 [73–91]

83 [73–93]

0.752

0.578

0.452

Hemoglobin, mmol/l

9.1 [8.6–9.5]

8.9 [8.6–9.5]

0.519

9.0 [8.6–9.5]

8.9 [8.5–9.2]

0.621

9.0 [8.6–9.9]

9.2 [8.7–9.7]

0.246

9.3 [8.4–9.7]

8.9 [8.4–9.6]

0.039

0.850

0.179

Leukocytes, 10e9/l

6.0 [5.3–7.1]

5.8 [5.4–6.9]

0.768

5.6 [4.5–6.0]

5.7 [4.6–5.9]

0.598

6.0 [5.2–6.9]

6.2 [5.3–6.6]

0.944

6.9 [4.8–8.4]

6.6 [4.7–8.2]

1.000

0.202

0.970

Thrombocytes,10e9/l

212 [194–252]

210 [206–241]

0.119

222 [186–254]

213 [185–245]

0.832

204 [196–242]

210 [202–237]

0.092

221 [190–300]

214 [207–267]

0.345

0.883

0.325

AST, U/l

25 [22–28]

27 [24–29]

0.182

24 [22–28]

26 [23–29]

0.291

27 [21–31]

26 [23–29]

0.619

25 [22–31]

28 [23–33]

0.105

0.741

0.305

ALT, U/l

33 [24–39]

30 [24–38]

0.626

34 [21–39]

29 [22–39]

0.798

36 [20–46]

32 [20–47]

0.916

31 [24–34]

30 [23–37]

0.611

0.873

0.964

AP, U/l

64 [55–77]

69 [57–78]

0.077

61 [50–82]

69 [51–79]

0.325

61 [50–75]

63 [50–74]

1.000

70 [60–90]

75 [60–89]

0.079

0.489

0.294

γGT, U/l

32 [22–43]

29 [22–42]

0.369

33 [20–42]

30 [20–42]

0.833

29 [21–43]

30 [22–40]

0.916

34 [24–68]

28 [23–63]

0.345

0.690

0.809

CRP, mg/ml

1.8 [1.0–4.8]

2.2 [1.0–4.1]

0.856

1.2 [0.8–3.9]

2.8 [1.1–5.1]

0.091

3.7 [0.8–9.5]

1.9 [1.1–3.4]

0.310

1.8 [1.0–5.1]

2.5 [0.9–4.4]

0.786

0.558

0.161

Caloric intake, kcal/day

1791 [1568–2028]

1871 [1694–1969]

0.798

1717 [1322–2002]

1676 [1519–1817]

0.893

1801 [1599–2028]

1785 [1594–2131]

0.753

1963 [1566–2424]

1969 [1890–2354]

0.401

0.305

0.739

Fat intake, g

75 [54–88]

65 [46–86]

0.449

60 [46–77]

48 [41–65]

0.109

76 [52–87]

55 [43–82]

0.345

83 [60–100]

86 [78–107]

0.093

0.297

0.045

Protein intake, g

84 [68–101]

92 [69–108]

0.717

80 [56–99]

92 [67–103]

0.345

98 [79–104]

92 [57–120]

0.917

74 [67–124]

90 [67–125]

0.889

0.641

0.777

Fiber intake, g

14 [13–19]

16 [12–22]

0.190

14 [14–19]

17 [14–24]

0.141

16 [13–20]

18 [9–26]

0.458

14 [12–23]

15 [10–24]

0.574

0.958

0.794

Carbohydrate intake, g

179 [165–200]

188 [173–250]

0.036

169 [158–195]

178 [164–217]

0.138

184 [157–196]

215 [184–263]

0.116

184 [167–215]

175 [167–278]

0.401

0.502

0.443

Compliance, %

100

100

 

100

100

 

100

100

 

100

100

   

qPCR fecal A. soehngenii, gene copies/g feces

1.6 × 106 [0.5 × 106–3.2 × 106]

1.2 × 109 [2.6 × 107–7.3 × 109]

1.2 × 10−7

1.8 × 106 [1.4 × 106–3.7 × 106]

1.4 × 107 [5.4 × 106–2.1 × 107]

0.012

0.9 × 106 [0.2 × 106–2.3 × 106]

1.7 × 109 [8.6 × 108–2.7 × 109]

0.012

1.4 × 106 [0.5 × 106–3.4 × 106]

1.9 × 1010 [0.9 × 1010–3.6 × 1011]

0.012

0.505

0.0001

  1. Shown are baseline characteristics at week 0 and safety parameters at week 0 and week 4 expressed as median [inter-quartile range] for all three treatment groups. p-values represent within-group changes between week 0 and 4 (p, paired Wilcoxon tests), between-group differences at baseline (p*, Kruskal–Wallis tests) and between-groups comparison of changes between week 0 and week 4 (p**, Kruskal–Wallis tests). A p-value < 0.05 was considered significant. Significant p-values are shown in bold. Measurement units are shown in italics.
  2. BMI body mass index, HbA1c glycated hemoglobin, HDL high-density lipoprotein, HOMA-IR homeostatic model assessment of insulin resistance, LDL low-density lipoprotein, AST aspartate transaminase, ALT alanine transaminase, AP alkaline phosphatase, γGT gamma-glutamyltransferase, CRP c-reactive protein.
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