Subject characteristics and effects on CVD risk at the start of the trial and after 3 months of treatment
| . | Placebo . | . | . | Isoflavones . | . | . | P for between-treatment difference . | P for period effect . | P for crossover effect . | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Baseline . | 3 months . | Percent change between baseline and 3 months . | Baseline . | 3 months . | Percent change between baseline and 3 months . | . | . | . | ||||
| BMI (kg/m2) | 31 ± 6.4 | 30.7 ± 5.5 | 0.01 (−0.55 to 0.59) | 30.7 ± 5.5 | 30.7 ± 5.5 | 0.02 (−0.69 to 0.75) | 0.97 | 0.1 | 0.7 | ||||
| Blood pressure (mmHg) | |||||||||||||
| Systolic | 133 ± 15 | 137 ± 16 | 4.26 (−1.28 to 9.8) | 130 ± 16 | 129 ± 12 | 0.69 (−3.44 to 4.8) | 0.35 | 0.5 | 0.9 | ||||
| Diastolic | 75 ± 10 | 76 ± 8 | 2.79 (−2.99 to 8.57) | 73 ± 9 | 74 ± 9 | −0.24 (−4.23 to 3.76) | 0.38 | 0.5 | 0.7 | ||||
| A1C (%) | 6.7 ± 0.6 | 6.8 ± 0.7 | 1.00 (−0.20 to 2.2) | 6.7 ± 0.7 | 6.8 ± 0.6 | 1.56 (−0.43 to 3.5) | 0.58 | 0.5 | 0.2 | ||||
| Plasma glucose (mmol/l) | 7.0 ± 1.4 | 6.9 ± 1.3 | −0.34 (−3.6 to 2.9) | 6.9 ± 1.3 | 6.8 ± 1.2 | −1.6 (−4.3 to 1.13) | 0.59 | 0.1 | 0.1 | ||||
| Insulin (μU/ml) | 14.1 ± 10 | 13 ± 6.9 | −0.39 (−12 to 11.2) | 12.8 ± 8.1 | 14.1 ± 9.2 | −13.4 (−27.3 to 0.38) | 0.15 | 0.4 | 0.5 | ||||
| HOMA-IR | 4.6 ± 4.5 | 4.5 ± 2.5 | −4.49 (−15.58 to 6.6) | 4.03 ± 3.3 | 4.5 ± 3.8 | −15.95 (−31.1 to 0.77) | 0.24 | 0.5 | 0.7 | ||||
| Cholesterol (mmol/l) | |||||||||||||
| Total | 5.4 ± 1 | 5.4 ± 0.9 | 2.14 (−7.54 to 3.25) | 5.4 ± 1 | 5.5 ± 0.9 | 2.01 (−6.4 to 2.4) | 0.96 | 0.3 | 0.9 | ||||
| LDL | 3.4 ± 0.9 | 3.4 ± 0.8 | 3.6 (−10.5 to 3.1) | 3.4 ± 0.8 | 3.5 ± 0.9 | 3.85 (−9.9 to 2.2) | 0.97 | 0.2 | 0.7 | ||||
| HDL | 1.2 ± 0.3 | 1.2 ± 0.3 | 0.37 (−3.69 to 4.4) | 1.2 ± 0.3 | 1.2 ± 0.3 | 0.16 (−3.4 to 3.6) | 0.93 | 0.8 | 0.4 | ||||
| Triglycerides (mmol/l) | 1.8 ± 0.8 | 1.7 ± 0.7 | −4.16 (−16.2 to −7.9) | 1.9 ± 0.9 | 1.8 ± 0.9 | −1.19 (−13,3 to 10.9) | 0.74 | 0.8 | 0.2 | ||||
| CRP (mg/l) | 5.1 ± 6.7 | 6.4 ± 10.1 | 24.4 (−46.5 to 2.21) | 5.4 ± 8 | 6.2 ± 8 | 44 (−43.5 to 133) | 0.40 | 0.3 | 0.4 | ||||
| . | Placebo . | . | . | Isoflavones . | . | . | P for between-treatment difference . | P for period effect . | P for crossover effect . | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Baseline . | 3 months . | Percent change between baseline and 3 months . | Baseline . | 3 months . | Percent change between baseline and 3 months . | . | . | . | ||||
| BMI (kg/m2) | 31 ± 6.4 | 30.7 ± 5.5 | 0.01 (−0.55 to 0.59) | 30.7 ± 5.5 | 30.7 ± 5.5 | 0.02 (−0.69 to 0.75) | 0.97 | 0.1 | 0.7 | ||||
| Blood pressure (mmHg) | |||||||||||||
| Systolic | 133 ± 15 | 137 ± 16 | 4.26 (−1.28 to 9.8) | 130 ± 16 | 129 ± 12 | 0.69 (−3.44 to 4.8) | 0.35 | 0.5 | 0.9 | ||||
| Diastolic | 75 ± 10 | 76 ± 8 | 2.79 (−2.99 to 8.57) | 73 ± 9 | 74 ± 9 | −0.24 (−4.23 to 3.76) | 0.38 | 0.5 | 0.7 | ||||
| A1C (%) | 6.7 ± 0.6 | 6.8 ± 0.7 | 1.00 (−0.20 to 2.2) | 6.7 ± 0.7 | 6.8 ± 0.6 | 1.56 (−0.43 to 3.5) | 0.58 | 0.5 | 0.2 | ||||
| Plasma glucose (mmol/l) | 7.0 ± 1.4 | 6.9 ± 1.3 | −0.34 (−3.6 to 2.9) | 6.9 ± 1.3 | 6.8 ± 1.2 | −1.6 (−4.3 to 1.13) | 0.59 | 0.1 | 0.1 | ||||
| Insulin (μU/ml) | 14.1 ± 10 | 13 ± 6.9 | −0.39 (−12 to 11.2) | 12.8 ± 8.1 | 14.1 ± 9.2 | −13.4 (−27.3 to 0.38) | 0.15 | 0.4 | 0.5 | ||||
| HOMA-IR | 4.6 ± 4.5 | 4.5 ± 2.5 | −4.49 (−15.58 to 6.6) | 4.03 ± 3.3 | 4.5 ± 3.8 | −15.95 (−31.1 to 0.77) | 0.24 | 0.5 | 0.7 | ||||
| Cholesterol (mmol/l) | |||||||||||||
| Total | 5.4 ± 1 | 5.4 ± 0.9 | 2.14 (−7.54 to 3.25) | 5.4 ± 1 | 5.5 ± 0.9 | 2.01 (−6.4 to 2.4) | 0.96 | 0.3 | 0.9 | ||||
| LDL | 3.4 ± 0.9 | 3.4 ± 0.8 | 3.6 (−10.5 to 3.1) | 3.4 ± 0.8 | 3.5 ± 0.9 | 3.85 (−9.9 to 2.2) | 0.97 | 0.2 | 0.7 | ||||
| HDL | 1.2 ± 0.3 | 1.2 ± 0.3 | 0.37 (−3.69 to 4.4) | 1.2 ± 0.3 | 1.2 ± 0.3 | 0.16 (−3.4 to 3.6) | 0.93 | 0.8 | 0.4 | ||||
| Triglycerides (mmol/l) | 1.8 ± 0.8 | 1.7 ± 0.7 | −4.16 (−16.2 to −7.9) | 1.9 ± 0.9 | 1.8 ± 0.9 | −1.19 (−13,3 to 10.9) | 0.74 | 0.8 | 0.2 | ||||
| CRP (mg/l) | 5.1 ± 6.7 | 6.4 ± 10.1 | 24.4 (−46.5 to 2.21) | 5.4 ± 8 | 6.2 ± 8 | 44 (−43.5 to 133) | 0.40 | 0.3 | 0.4 | ||||
Data are means ± SD or means(95% CI). The percentages of change in each group were comparedto obtain the P values for the between-treatment difference. CRP, C-reactive protein.