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Table 1 Baseline characteristics of subjects (full analysis set)

From: Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study

Variable Be Bi BB Placebo P value
n (%) 49 (98.00) 100 (100.00) 49 (98.00) 99 (99.00)  
Age, years 53.28 ± 9.87 54.16 ± 9.10 53.36 ± 9.49 52.73 ± 9.35 0.761
Sex (male), n (%) 23 (46.94) 59 (59.00) 27 (55.10) 54 (54.55) 0.585
BW, kg 68.37 ± 10.82 69.57 ± 9.06 69.04 ± 10.48 69.58 ± 11.24 0.904
BMI, kg/m2 25.05 ± 2.68 25.25 ± 2.28 25.20 ± 2.69 25.02 ± 2.80 0.921
Waist circumference, cm 90.08 ± 9.25 90.98 ± 7.58 91.82 ± 8.13 91.13 ± 8.58 0.774
Hip circumference, cm 98.17 ± 5.73 98.72 ± 7.74 98.60 ± 6.20 98.10 ± 6.81 0.920
Systolic blood pressure, mmHg 120.56 ± 11.88 123.08 ± 12.42 121.17 ± 13.75 122.71 ± 11.37 0.591
Diastolic blood pressure, mmHg 77.46 ± 8.94 78.57 ± 8.19 77.97 ± 7.82 76.86 ± 7.68 0.516
Pulse, beats/min 73.14 ± 8.29 74.15 ± 8.56 74.80 ± 7.20 74.17 ± 9.18 0.812
ECG      0.225
 Normal, n (%) 39 (79.59) 64 (64.00) 29 (59.18) 63 (63.64)  
 Non-clinical significance, n (%) 9 (18.37) 33 (33.00) 17 (34.69) 26 (26.26)  
 Clinical significance, n (%) 1 (2.04) 3 (3.00) 3 (6.12) 9 (9.09)  
 None, n (%) 0 (0.00) 0 (0.00) 0 (0.00) 1 (1.01)  
FPG, mmol/L 6.49 ± 0.64 6.40 ± 0.66 6.42 ± 0.77 6.43 ± 0.71 0.881
30 min post-plasma glucose, mmol/L 12.12 ± 1.63 11.93 ± 1.84 11.76 ± 2.09 11.94 ± 1.86 0.830
2-hr PPG, mmol/L 11.17 ± 2.41 11.40 ± 3.08 11.24 ± 2.37 11.62 ± 3.08 0.906
HbA1c, % 6.19 ± 0.53 6.19 ± 0.59 6.12 ± 0.72 6.23 ± 0.68 0.920
Fasting serum insulin, μIU/mL 9.87 (5.91–13.60) 10.52 (7.65–13.88) 9.56 (7.49–13.89) 9.78 (6.69–11.98) 0.430
30 min post-serum insulin, μIU/mL 39.16 (21.46–64.74) 33.00 (19.75–61.83) 34.30 (20.40–51.74) 32.98 (23.88–52.84) 0.962
2-hr post-serum insulin, μIU/mL 61.85 (40.88–94.43) 58.56 (40.50–84.36) 69.15 (46.19–88.76) 56.26 (36.35–79.12) 0.279
Fasting serum C peptide, ng/mL 1.46 (0.60–2.04) 1.58 (0.60–2.28) 1.38 (0.72–2.13) 1.47 (0.63–2.13) 0.995
30 min post-serum C peptide, ng/mL 3.29 (2.07–4.44) 2.67 (1.52–3.87) 2.76 (1.77–3.84) 2.79 (1.08–4.53) 0.711
2-hr post-serum C peptide, ng/mL 6.01 (3.09–8.92) 5.64 (2.16–8.74) 6.76 (3.39–8.35) 5.82 (2.40–8.32) 0.745
TG, mmol/L 2.12 (1.50–2.61) 1.71 (1.21–2.46) 1.66 (1.03–2.14) 1.83 (1.20–2.35) 0.253
TC, mmol/L 5.03 ± 1.15 4.76 ± 1.01 4.44 ± 0.96 4.72 ± 0.88 0.035
HDL-C, mmol/L 1.15 ± 0.30 1.19 ± 0.31 1.12 ± 0.27 1.15 ± 0.26 0.535
LDL-C, mmol/L 3.00 ± 0.88 2.85 ± 0.80 2.67 ± 0.84 2.81 ± 0.79 0.260
HOMA-IR 2.69 (1.76–3.41) 3.05 (1.88–4.08) 2.74 (2.16–3.95) 2.75 (1.89–3.45) 0.450
HOMA-β 69.66 (42.97–98.37) 71.98 (53.23–105.48) 68.00 (46.41–96.77) 63.53 (48.40–87.79) 0.832
Fasting GLP-1, pmol/L 2.38 (1.64–5.24) 2.00 (1.53–5.11) 2.95 (1.52–5.82) 2.71 (1.66–5.99) 0.895
30 min post-GLP-1, pmol/L 4.39 (2.71–7.03) 4.62 (2.62–7.29) 3.77 (2.62–7.28) 3.98 (2.37–6.97) 0.982
2-hr post-GLP-1, pmol/L 2.31 (1.24–4.34) 2.48 (1.80–5.04) 3.32 (1.92–5.32) 2.48 (1.40–5.04) 0.745
Area under the curve of GLP-1 7.48 (4.53–14.40) 8.13 (4.91–12.90) 6.99 (5.31–13.69) 6.95 (4.72–13.34) 0.905
  1. Data were presented as n (%), mean ± standard deviation, and median (range interquartile). P value: comparison among the groups after treatment
  2. ECG explanation: normal, normal ECG; non-clinical significance, abnormal ECG without any clinical significance; clinical significance, abnormal ECG with clinical significance; none, ECG was not performed
  3. HOMA-IR: (fasting serum insulin × fasting plasma glucose)/22.5, homeostasis model assessment index for assessing insulin resistance; HOMA-β: (20 × fasting serum insulin)/(fasting plasma glucose − 3.5), homeostasis model assessment index for assessing β cell function. P value: comparison among the groups; Be: treatment with berberine; Bi: treatment with Bifidobacterium; BB: treatment with berberine and Bifidobacterium
  4. BW body weight, BMI body mass index, FPG fasting plasma glucose, 2-hr PPG 2-hour postprandial plasma glucose, TG triglyceride, TC total cholesterol, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, ECG electrocardiogram