Demographic characteristics of each study group
| Variable | Statistic | Group A | Group B | Group C | Group D1 | Group D2 | All subjects |
|---|---|---|---|---|---|---|---|
| No. of subjects | - | 4 | 4 | 4 | 4 | 4 | 20 |
| Dose (CFU)a | - | 1 × 1011 | 3 × 1011 | 6 × 1011 | 9 × 1011 | 9 × 1011 | - |
| Dietary controlb (N/Y) | - | N | N | N | N | Y | - |
| Sex | - | Male | Male | Male | Male | Male | - |
| Age (y) | Mean (SD) | 34.00 (13.14) | 27.50 (9.47) | 25.00 (1.63) | 25.00 (3.56) | 26.50 (2.65) | 27.60 (7.53) |
| Height (cm) | Mean (SD) | 170.13 (8.63) | 177.18 (7.99) | 174.13 (5.45) | 173.58 (8.95) | 173.95 (3.86) | 173.79 (6.84) |
| Weight (kg) | Mean (SD) | 70.13 (6.77) | 79.30 (12.67) | 72.18 (2.36) | 72.25 (9.89) | 78.75 (3.37) | 74.52 (8.10) |
| BMI (kg/m2) | Mean (SD) | 24.20 (2.06) | 25.15 (2.89) | 23.75 (0.90) | 23.88 (2.22) | 25.98 (1.04) | 24.59 (1.95) |
| Alcohol (g/wk) | |||||||
| Yes | n (%) | 4 (100.0) | 0 (0.0) | 3 (75.0) | 4 (100.0) | 1 (25.0) | 12 (60.0) |
| No | n (%) | 0 (0.0) | 4 (100.0) | 1 (25.0) | 0 (0.0) | 3 (75.0) | 8 (40.0) |
| Caffeine (cups/day) | |||||||
| Yes | n (%) | 3 (75.0) | 3 (75.0) | 3 (75.0) | 2 (50.0) | 1 (25.0) | 12 (60.0) |
| No | n (%) | 1 (25.0) | 1 (25.0) | 1 (25.0) | 2 (50.0) | 3 (75.0) | 8 (40.0) |
Group A, administration of 1 capsule; Group B, administration of 3 capsules; Group C, administration of 6 capsules; Group D1, administration of 9 capsules without dietary control; Group D2, administration of 9 capsules with dietary control; BMI, body mass index; SD, standard deviation. aCFU, colony forming unit. 1 capsule is 1 × 1011 CFU. bGroup D2 was dietary controlled a week before GEN-001 administration.