Table 1.
Baseline characteristics and number of study visits of 197 female subjects randomized to treatment with placebo or soy isoflavones *, †, ‡
| Variables | Placebo | Isoflavone | ||
|---|---|---|---|---|
| n0 | Mean ± SD; % | n1 | Mean ± SD; % | |
| Age at study consent (yr) | 98 | 37.35 ± 3.45 | 99 | 37.58 ± 2.95 |
| Race/Ethnicity (%) | 98 | 49.75 | 99 | 50.25 |
| Hispanic | 39 | 39.80 | 51 | 51.52 |
| African American | 12 | 12.24 | 14 | 14.14 |
| White | 47 | 47.96 | 34 | 34.34 |
| At study site | ||||
| Body weight (kg) | 98 | 74.99 ± 17.33 | 99 | 73.46 ± 16.62 |
| Height (cm) | 98 | 160.21 ± 6.01 | 99 | 160.69 ± 7.63 |
| BMI (kg/m2) | 98 | 29.17 ± 6.33 | 99 | 28.45 ± 6.05 |
| Waist circumference (cm) | 97 | 90.83 ± 13.79 | 99 | 89.60 ± 13.14 |
| Hip circumference (cm) | 97 | 109.02 ± 12.95 | 99 | 108.10 ± 11.40 |
| Waist-to-hip circumferenceratio | 97 | 0.83 ± 0.06 | 99 | 0.83 ± 0.06 |
| Systolic blood pressure (mmHg) | 98 | 119.27 ± 14.85 | 99 | 115.55 ± 14.07 |
| Diastolic blood pressure (mmHg) | 98 | 71.51 ± 9.08 | 99 | ;69.47 ± 9.09 |
| Urinary level | ||||
| Riboflavin concentration (μg/mL) | 91 | 0.66 ± 1.00 | 93 | 0.82 ± 1.72 |
| Riboflavin excretion (mg/h) | 91 | 0.05 ± 0.08 | 93 | 0.06 ± 0.01 |
| Daidzeinexcretion (mg/h) | 90 | 0.06 ± 0.03 | 89 | 0.07 ± 0.04 |
| Genistein excretion (mg/h) | 90 | 0.08 ± 0.05 | 89 | 0.08 ± 0.04 |
| Serum level | ||||
| Total protein (g/dL) | 98 | 7.54 ± 0.50 | 98 | 7.50 ± 0.45 |
| Albumin (g/dL) | 98 | 4.28 ± 0.34 | 99 | 4.28 ± 0.26 |
| Calcium (mg/dL) | 98 | 9.01 ± 0.35 | 99 | 9.05 ± 0.28 |
| Chloride (mEq/L) | 98 | 105.27 ± 1.91 | 99 | 105.49 ± 1.85 |
| Potassium (mEq/L) | 98 | 4.04 ± 0.22 | 99 | 4.07 ± 0.24 |
| Sodium (mEq/L) | 98 | 140.50 ± 1.47 | 99 | 140.67 ± 1.50 |
| Study visits (n) | 98 | 8.60 ± 3.00 | 99 | 8.70 ± 3.10 |
*
Variables were average of 4 baseline screening visits except for race/ethnicity. Study visitswere mean number of baseline and completed follow-up visit.
†
Means and standard deviations (SDs) for numerical variables and the percentage for categorical variables are stratified by groups.
‡
For race/ethnicity, the P value between groups was 0.15 (Fisher’s exact test). For numerical variables, all P values between groups were greater than 0.05.