Changes from baseline in study measurements on the basis of raw data and significance of treatment differences for raw and multiple imputation
| . | Control diet . | . | Test diet . | . | Between diets . | ||||
|---|---|---|---|---|---|---|---|---|---|
| . | Week 0 (n = 71)b . | Changea within diet . | . | Week 0 (n = 70)b . | Changea within diet . | . | Changea . | P value (raw) . | P value (MI) . |
| Weight (kg) | 84.4 (79.9, 88.9) | −1.6 (−2.0, −1.3) | * | 84.5 (79.7, 89.4) | −2.1 (−2.5, −1.7) | * | −0.5 (−1.0, 0.0) | 0.070 | 0.458 |
| Waist (cm) | 106 (103, 110) | −2.4 (−2.9, −1.9) | * | 104 (101, 108) | −1.8 (−2.4, −1.3) | * | 0.6 (−0.2, 1.3) | 0.143 | 0.065 |
| HbA1c (% HbA1c unit) | 7.2 (7.1, 7.4) | −0.31 (−0.38, −0.25) | * | 7.4 (7.2, 7.5) | −0.47 (−0.54, −0.40) | * | −0.16 (−0.25, −0.06) | 0.002 | 0.016 |
| HbA1c (mmol/mol) | 55.7 (54.1, 57.3) | −3.44 (−4.17, −2.71) | 57.1 (55.4, 58.8) | −5.15 (−5.92, −4.38) | −1.71 (−2.77, −0.65) | ||||
| Fasting glucose (mmol/L) | 7.5 (7.1, 7.9) | −0.30 (−0.48, −0.12) | * | 7.7 (7.3, 8.0) | −0.37 (−0.56, −0.18) | * | −0.07 (−0.33, 0.19) | 0.591 | 0.491 |
| Cholesterol (mmol/L) | 4.0 (3.8, 4.2) | 0.04 (−0.03, 0.12) | 4.1 (3.9, 4.4) | −0.30 (−0.38, −0.22) | * | −0.34 (−0.46, −0.23) | 0.000 | 0.000 | |
| LDL-C (mmol/L) | 2.1 (1.9, 2.3) | 0.04 (−0.02, 0.11) | 2.2 (2.0, 2.5) | −0.20 (−0.27, −0.13) | * | −0.25 (−0.34, −0.15) | 0.000 | 0.000 | |
| HDL-C (mmol/L) | 1.2 (1.1, 1.2) | 0.00 (−0.02, 0.02) | 1.2 (1.1, 1.3) | −0.03 (−0.05, −0.01) | * | −0.03 (−0.06, 0.00) | 0.041 | 0.164 | |
| Triglycerides (mmol/L) | 1.5 (1.3, 1.7) | −0.01 (−0.09, 0.07) | 1.5 (1.4, 1.7) | −0.15 (−0.24, −0.07) | * | −0.14 (−0.26, −0.03) | 0.018 | 0.085 | |
| Total cholesterol/HDL-C | 3.6 (3.3, 3.8) | 0.02 (−0.05, 0.10) | 3.6 (3.3, 3.8) | −0.19 (−0.27, −0.11) | * | −0.21 (−0.32, −0.11) | 0.000 | 0.000 | |
| LDL-C/HDL-C | 1.9 (1.7, 2.1) | 0.03 (−0.03, 0.09) | 1.9 (1.7, 2.1) | −0.13 (−0.19, −0.07) | * | −0.16 (−0.24, −0.07) | 0.001 | 0.000 | |
| Systolic BP (mmHg) | 122 (120, 125) | −5.1 (−6.7, −3.5) | * | 121 (118, 124) | −4.7 (−6.4, −2.9) | * | 0.4 (−1.9, 2.8) | 0.718 | 0.892 |
| Diastolic BP (mmHg) | 72 (70, 74) | −3.3 (−4.2, −2.3) | * | 71 (69, 73) | −3.0 (−4.1, −2.0) | * | 0.2 (−1.2, 1.7) | 0.740 | 0.763 |
| Heart rate (bpm) | 73 (71, 76) | −2.6 (−3.6, −1.6) | * | 73 (70, 75) | −2.3 (−3.4, −1.3) | * | 0.2 (−1.2, 1.7) | 0.770 | 0.898 |
| Absolute CVD riskc (10-year %) | 10.3 (9.1, 11.5) | −0.53 (−0.84, −0.22) | * | 9.6 (8.8, 10.5) | −1.16 (−1.49, −0.82) | * | −0.63 (−1.09, −0.17) | 0.008 | 0.079 |
| Relative CVD risk | 1.3 (1.2, 1.5) | −0.07 (−0.12, −0.03) | * | 1.3 (1.2, 1.4) | −0.16 (−0.20, −0.11) | * | −0.08 (−0.15, −0.02) | 0.007 | 0.049 |
| RHI ratio | 1.7 (1.6, 1.8) | 0.13 (0.00, 0.25) | 1.9 (1.7, 2.0) | −0.12 (−0.24, 0.01) | −0.24 (−0.42, −0.06) | 0.009 | 0.015 | ||
| . | Control diet . | . | Test diet . | . | Between diets . | ||||
|---|---|---|---|---|---|---|---|---|---|
| . | Week 0 (n = 71)b . | Changea within diet . | . | Week 0 (n = 70)b . | Changea within diet . | . | Changea . | P value (raw) . | P value (MI) . |
| Weight (kg) | 84.4 (79.9, 88.9) | −1.6 (−2.0, −1.3) | * | 84.5 (79.7, 89.4) | −2.1 (−2.5, −1.7) | * | −0.5 (−1.0, 0.0) | 0.070 | 0.458 |
| Waist (cm) | 106 (103, 110) | −2.4 (−2.9, −1.9) | * | 104 (101, 108) | −1.8 (−2.4, −1.3) | * | 0.6 (−0.2, 1.3) | 0.143 | 0.065 |
| HbA1c (% HbA1c unit) | 7.2 (7.1, 7.4) | −0.31 (−0.38, −0.25) | * | 7.4 (7.2, 7.5) | −0.47 (−0.54, −0.40) | * | −0.16 (−0.25, −0.06) | 0.002 | 0.016 |
| HbA1c (mmol/mol) | 55.7 (54.1, 57.3) | −3.44 (−4.17, −2.71) | 57.1 (55.4, 58.8) | −5.15 (−5.92, −4.38) | −1.71 (−2.77, −0.65) | ||||
| Fasting glucose (mmol/L) | 7.5 (7.1, 7.9) | −0.30 (−0.48, −0.12) | * | 7.7 (7.3, 8.0) | −0.37 (−0.56, −0.18) | * | −0.07 (−0.33, 0.19) | 0.591 | 0.491 |
| Cholesterol (mmol/L) | 4.0 (3.8, 4.2) | 0.04 (−0.03, 0.12) | 4.1 (3.9, 4.4) | −0.30 (−0.38, −0.22) | * | −0.34 (−0.46, −0.23) | 0.000 | 0.000 | |
| LDL-C (mmol/L) | 2.1 (1.9, 2.3) | 0.04 (−0.02, 0.11) | 2.2 (2.0, 2.5) | −0.20 (−0.27, −0.13) | * | −0.25 (−0.34, −0.15) | 0.000 | 0.000 | |
| HDL-C (mmol/L) | 1.2 (1.1, 1.2) | 0.00 (−0.02, 0.02) | 1.2 (1.1, 1.3) | −0.03 (−0.05, −0.01) | * | −0.03 (−0.06, 0.00) | 0.041 | 0.164 | |
| Triglycerides (mmol/L) | 1.5 (1.3, 1.7) | −0.01 (−0.09, 0.07) | 1.5 (1.4, 1.7) | −0.15 (−0.24, −0.07) | * | −0.14 (−0.26, −0.03) | 0.018 | 0.085 | |
| Total cholesterol/HDL-C | 3.6 (3.3, 3.8) | 0.02 (−0.05, 0.10) | 3.6 (3.3, 3.8) | −0.19 (−0.27, −0.11) | * | −0.21 (−0.32, −0.11) | 0.000 | 0.000 | |
| LDL-C/HDL-C | 1.9 (1.7, 2.1) | 0.03 (−0.03, 0.09) | 1.9 (1.7, 2.1) | −0.13 (−0.19, −0.07) | * | −0.16 (−0.24, −0.07) | 0.001 | 0.000 | |
| Systolic BP (mmHg) | 122 (120, 125) | −5.1 (−6.7, −3.5) | * | 121 (118, 124) | −4.7 (−6.4, −2.9) | * | 0.4 (−1.9, 2.8) | 0.718 | 0.892 |
| Diastolic BP (mmHg) | 72 (70, 74) | −3.3 (−4.2, −2.3) | * | 71 (69, 73) | −3.0 (−4.1, −2.0) | * | 0.2 (−1.2, 1.7) | 0.740 | 0.763 |
| Heart rate (bpm) | 73 (71, 76) | −2.6 (−3.6, −1.6) | * | 73 (70, 75) | −2.3 (−3.4, −1.3) | * | 0.2 (−1.2, 1.7) | 0.770 | 0.898 |
| Absolute CVD riskc (10-year %) | 10.3 (9.1, 11.5) | −0.53 (−0.84, −0.22) | * | 9.6 (8.8, 10.5) | −1.16 (−1.49, −0.82) | * | −0.63 (−1.09, −0.17) | 0.008 | 0.079 |
| Relative CVD risk | 1.3 (1.2, 1.5) | −0.07 (−0.12, −0.03) | * | 1.3 (1.2, 1.4) | −0.16 (−0.20, −0.11) | * | −0.08 (−0.15, −0.02) | 0.007 | 0.049 |
| RHI ratio | 1.7 (1.6, 1.8) | 0.13 (0.00, 0.25) | 1.9 (1.7, 2.0) | −0.12 (−0.24, 0.01) | −0.24 (−0.42, −0.06) | 0.009 | 0.015 | ||
Data are mean (lower confidence limit, upper confidence limit). Physical and biochemical measures were obtained at week 0, representing baseline, and weeks 8, 10, and 12 − baseline, representing change from baseline. BP, blood pressure; MI, multiple imputation; RHI, reactive hyperemia index.
*Significant difference from baseline (P < 0.05).
aMean, confidence limits, and P values determined using repeated-measures least squares means in PROC MIXED of SAS 9.2 with all available data.
bControl: n = 71 at baseline and 64, 60, and 59 at weeks 8, 10, and 12, respectively. Test: n = 70 at baseline and 54 at weeks 8, 10, and 12.
cCVD risk calculated using the Framingham CVD predictive equation by Anderson et al. (22).