TABLE 1.
Baseline characteristics of the study group.
| Variables | Intention to treat population |
Per protocol population |
||||
| FO (n = 27) | Placebo (n = 27) | pa | FO (n = 26) | Placebo (n = 23) | pa | |
| Age, years | 58.1 ± 6.7 | 59.3 ± 5.1 | 0.441 | 58.2 ± 6.8 | 59.4 ± 5.3 | 0.494 |
| Males, % | 3 (11.1) | 8 (29.6) | 0.091 | 3 (11.5) | 7 (30.4) | 0.101 |
| Systolic BP, mmHg | 124.4 ± 13.9 | 126.9 ± 14.0 | 0.503 | 124.4 ± 14.2 | 126.6 ± 15.1 | 0.591 |
| Diastolic BP, mmHg | 78.5 ± 10.1 | 82.4 ± 10.3 | 0.162 | 78.2 ± 10.2 | 82.3 ± 11.1 | 0.184 |
| Current smoker,% | 1 (3.7) | 0 (0.0) | 1.000 | 1 (3.8) | 0 (0.0) | 1.000 |
| Alcohol drinker, % | 6 (22.2) | 5 (18.5) | 0.735 | 5 (19.2) | 4 (17.4) | 0.670 |
| Co-morbiditiesb | 8 (29.6) | 11 (40.7) | 0.393 | 8 (30.8) | 10 (43.5) | 0.357 |
| Hypertension | 3 (11.1) | 6 (22.2) | 3 (11.5) | 6 (26.1) | ||
| Diabetes mellitus | 2 (7.4) | 3 (11.1) | 2 (7.7) | 3 (13.0) | ||
| Dyslipidemia | 2 (7.4) | 5 (18.5) | 2 (7.7) | 5 (21.7) | ||
| Others | 5 (18.5) | 4 (14.8) | 5 (19.2) | 4 (17.4) | ||
| Body mass index, kg/m2 | 23.6 ± 3.2 | 23.7 ± 2.1 | 0.861 | 23.3 ± 3.0 | 23.6 ± 2.2 | 0.728 |
| Energy intake, Kcal/day | 1,527.2 ± 428.1 | 1,495.1 ± 507.4 | 0.802 | 1,531.1 ± 436.1 | 1,515.4 ± 516.2 | 0.909 |
| IPAQ (METs) | 1,215.0 [583.1−2,709.0] | 1,825.0 [749.3−3,445.3] | 0.236 | 1,256.0 [600.0−2,772.0] | 1,485.0 [618.8−3,443.3] | 0.631 |
Values are mean ± SD or n (%), except for IPAQ, which are median [IQR] unless otherwise indicated. FO, Fermented Oyster Extract; BP, blood pressure; IPAQ, international physical activity questionnaires; MET, metabolic equivalent task. aP-value by two-sample t-test for parametric variables, Mann-Whitney’s U-test for non-parametric variables, and the chi-square test or Fisher’s exact test for categorical variables. bIncluding multiple diseases.