Table 1.
Study-participant demographics
| Population demographic characteristics: ITT population | ||||
|---|---|---|---|---|
| Placebo (n = 29) | 500 mg UA (n = 29) | 1,000 mg UA (n = 30) | Between group p value∗ | |
| Age (years) (mean ± SD) | 54.38 ± 6.42 | 51.03 ± 7.16 | 52.07 ± 5.56 | 0.132 |
| Gender (n [%]) | 0.756 | |||
| Female (%) | 20 (69.00) | 18 (62.10) | 18 (60) | |
| Male (%) | 9 (31.00) | 11 (37.90) | 12 (40) | |
| Weight (kg) | 81.69 ± 9.44 | 82.93 ± 12.09 | 81.52 ± 11.45 | 0.868 |
| Ethnicity | Western European White (n = 21; 70%); others (n = 8; 30%) | Western European White (n = 23; 79.3%); others (n = 6; 20.7%) | Western European White (n = 22; 75.9%); others (n = 8; 20.7%) | 0.696 |
| BMI (kg/m2) (>25 kg/m2) | 29.30 ± 2.55 | 29.52 ± 2.82 | 28.91 ± 2.89 | 0.667 |
| Systolic blood pressure (mmHg) (mean ± SD) | 123.71 ± 11.92 | 124.78 ± 11.40 | 125.52 ± 10.24 | 0.824 |
| Diastolic blood pressure (mmHg) (mean ± SD) | 79.03 ± 8.68 | 78.41 ± 6.92 | 80.10 ± 7.25 | 0.694 |
| Heart rate (bpm) (mean ± SD) | 65.74 ± 9.61 | 67.60 ± 7.24 | 67.92 ± 8.56 | 0.575 |
| VO2max (mL/kg/min) | 23.09 ± 4.76 | 23.94 ± 4.80 | 23.27 ± 5.92 | 0.806 |
Eighty-eight subjects that successfully met all screening inclusion and exclusion criteria were randomized. The three different study groups were well balanced on age, gender, and physical characteristics. The average age of participants was similar: 51.03 + 7.16 years in UA 500 mg group versus 52.07 + 5.56 years in UA 1,000 mg group versus 54.38 + 6.48 years in the placebo group. Body mass index (BMI) across the different groups was comparable at baseline (29.52 + 2.82 kg/m2 in UA 500-mg groups versus 28.91 + 2.89 kg/m2 in UA 1,000-mg group versus 29.30 + 2.55 kg/m2 in the placebo group). Interventional groups were also well balanced for baseline endurance (VO2max in 500-mg group at 23.94 + 4.80 mL/kg/min versus 23.27 + 5.92 mL/kg/min in the UA 1,000 mg group versus 23.09 + 4.76 mL/kg/min in the placebo group) and vital signs.