Background
Methods
Subject selection
Intervention procedure
Blinding
Adverse effects
Supplementation and compliance
Measurements of outcomes
Assessment of probiotics recovery in stool
Statistical analysis
Results
Socio-demographic characteristics and compliance rate
Baseline parameters | Probiotic group (n = 68) | Placebo group (n = 68) | P value |
---|---|---|---|
Age | 52.9 ± 9.2 | 54.2 ± 8.3 | 0.362 |
Gender (male) | 37 (54.4 %) | 34 (50 %) | 0.731 |
Ethnicity | |||
• Malay | 31 (45.6 %) | 38 (55.8 %) | 0.601 |
• Chinese | 18 (26.4 %) | 17 (25 %) | |
• Indian | 16 (23.6 %) | 11 (16.2 %) | |
• Other races | 3 (4.4 %) | 2 (3 %) | |
HbA1c | 7.6 ± 1.3 | 7.5 ± 1.3 | 0.795† |
Physical characteristics | |||
• Weight (kg) | 74.6 ± 15.1 | 76.6 ± 15.6 | 0.514 |
• Height (cm) | 160.0 ± 8.4 | 161.8 ± 9.4 | 0.285 |
• BMI (kg/m2) | 29.2 ± 5.6 | 29.3 ± 5.3 | 0.837 |
• WC | |||
Male (cm)a | 100.4 ± 13.5 | 102.0 ± 13.7 | 0.429 |
Female (cm)b | 97.3 ± 14.6 | 96.7 ± 9.5 | 0.618 |
Diet intake | |||
• Energy (kcal) | 1473 ± 402 | 1508 ± 503 | |
• % of calorie by carbohydrate | 54.1 ± 7.9 | 53.9 ± 8.2 | 0.917 |
• % of calorie by protein | 16.3 ± 3.9 | 17.1 ± 3.7 | 0.612 |
• % of calories by fat | 29 ± 2 | 28.6 ± 5.4 | 0.917 |
• Fibre (gr) | 7 ± 5 | 6 ± 4 | 0.283† |
• Sodium (gr) | 1522 ± 639 | 1840 ± 919 | 0.065 |
Physical activity level | |||
• Total physical activity score (MET_min/wk) | 1784 ± 2100 | 1989 ± 1869 | 0.570 |
• Sedentary activity (hours/day) | 6.2 ± 3.3 | 5.5 ± 3.0 | 0.212 |
Renal profile | |||
Sodium (mmol/L) | 138.5 ± 2.2 | 137.9 ± 2.5 | 0.094 |
Potassium (mmol/L) | 4.42 ± 0.30 | 4.40 ± 0.40 | 0.284 |
Urea (mmol/L) | 4.26 ± 1.29 | 4.03 ± 0.89 | 0.069† |
Creatinine (μmol/L) | 69.20 ± 17.36 | 72.10 ± 18.84 | 0.326 |
GFR (ml/min) | 74.45 ± 18.5 | 73.66 ± 13.38 | 0.423 |
Liver function tests | |||
Albumin (g/L) | 45.64 ± 3.22 | 45.51 ± 2.53 | 0.713 |
Total protein (g/L) | 74.24 ± 4.93 | 73.87 ± 3.73 | 0.780 |
Bilirubin (μmol/L) | 9.77 ± 3.50 | 10.38 ± 3.92 | 0.417† |
ALT (U/L) | 23.20 ± 9.65 | 32.53 ± 16.10 | 0.001*† |
ALP (U/L) | 68.49 ± 23.19 | 73.42 ± 18.11 | 0.088 |
AST (U/L) | 20.1 ± 4.7 | 25.8 ± 7.1 | 0.002* |
Baseline parameters | Probiotic group (n = 68) | Placebo group (n = 68) | P value |
---|---|---|---|
n (%) | n (%) | ||
Diet alone | 6 (8.8 %) | 1 (1.4 %) | 0.660 |
Single OAD | 19 (28.0 %) | 16 (23.6 %) | 0.589 |
Dual OAD | 37 (54.4 %) | 40 (58.8 %) | 0.912 |
>2 types OAD | 6 (8.8 %) | 11 (16.2 %) | 0.486 |
On Antihypertensive | 47 (69.2 %) | 48 (70.6 %) | 0.943 |
On Anti-hyperlipidemic | 54 (79.4 %) | 58 (85.4 %) | 0.610 |
Obesity | 18 (26.5 %) | 14 (20.6 %) | 0.419 |
Attrition rate and incidence of adverse effects
Recovery of probiotics in stool
Changes in dietary intake and physical activity levels over the course of study
Changes in renal profile parameters over the course of study
Probiotic Group (n = 68) | Within group p value | Placebo Group (n = 68) | Within group p value | Interaction p value | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Mean ± SD | Mean ± SD | |||||||||
Baseline | Week 6 | Week 12 | Baseline | Week 6 | Week 12 | ITT | PP | |||
Renal profile | ||||||||||
Sodium (mmol/L)† | 138.5 ± 2.2 | 138.9 ± 2.7 | 138.1 ± 3.5 | 0.147 | 137.9 ± 2.5 | 138.8 ± 2.9 | 138.5 ± 3.1 | 0.167 | 0.235 | 0.280 |
Potassium (mmol/L) | 4.42 ± 0.30 | 4.42 ± 0.31 | 4.35 ± 0.31 | 0.060 | 4.40 ± 0.40 | 4.34 ± 0.36 | 4.37 ± 0.43 | 0.360 | 0.164 | 0.351 |
Urea (mmol/L) | 4.26 ± 1.29 | 4.03 ± 1.00 | 4.04 ± 1.04 | 0.086 | 4.03 ± 0.89 | 4.07 ± 1.10 | 4.24 ± 1.14 | 0.081 | <0.05 | 0.181 |
Creatinine (μmol/L) | 69.20 ± 17.36 | 70.87 ± 18.70 | 72.26 ± 19.73 | <0.05 | 72.10 ± 18.84 | 71.95 ± 18.60 | 75.17 ± 18.93 | <0.05 | 0.329 | 0.288 |
GFR (ml/min) | 74.45 ± 18.5 | 74.14 ± 16.94 | 73.07 ± 17.13 | 0.710 | 73.66 ± 13.38 | 73.91 ± 13.58 | 68.89 ± 13.55 | <0.05 | 0.147 | 0.197 |
Liver function tests | ||||||||||
Albumin (g/L) | 45.64 ± 3.22 | 45.38 ± 3.18 | 45.48 ± 2.97 | 0.551 | 45.51 ± 2.53 | 45.81 ± 2.05 | 45.94 ± 1.93 | 0.339 | 0.147 | 0.224 |
Total protein (g/L) | 74.24 ± 4.93 | 73.32 ± 5.14 | 73.03 ± 5.98 | 0.190 | 73.87 ± 3.73 | 72.33 ± 4.89 | 71.59 ± 5.19 | <0.05 | 0.695 | 0.534 |
Bilirubin (μmol/L)† | 9.77 ± 3.50 | 10.03 ± 3.59 | 10.09 ± 3.70 | 0.739 | 10.38 ± 3.92 | 10.27 ± 3.20 | 10.28 ± 3.20 | 0.996 | 0.260 | 0.845 |
ALT (U/L)† | 23.20 ± 9.65 | 22.38 ± 10.13 | 22.33 ± 10.02 | 0.199 | 32.53 ± 16.10 | 32.59 ± 16.78 | 33.27 ± 17.29 | 0.823 | 0.421 | 0.374 |
ALP (U/L) | 68.49 ± 23.19 | 68.28 ± 21.82 | 67.00 ± 21.77 | 0.209 | 73.42 ± 18.11 | 71.97 ± 18.57 | 71.29 ± 20.72 | 0.134 | 0.481 | 0.485 |
AST (U/L) | 26.84 ± 77.12 | 24.58 ± 6.64 | 25.71 ± 6.81 | 0.441 | 20.12 ± 4.68 | 20.26 ± 5.12 | 21.29 ± 6.30 | 0.275 | 0.490 | 0.495 |