Table 4 Primary and secondary outcomes of the Mediterranean diet and low-fat diet groups
Endpoint variable | Mediterranean diet group (n = 100) | Low-fat diet group (n = 92) | Difference | P value |
|---|---|---|---|---|
Primary outcome ITT population† | ||||
LDL cholesterol, mg/dL* | 66.5 (59.6, 73.4) | 69.9 (62.6, 77.2) | -3.4 (-13.4, 6.62) | 0.50 |
Secondary outcomes ITT population | ||||
Total cholesterol, mg/dL | 129.8 (121.9, 137.7) | 132.2 (123.9, 140.5) | -2.41 (-13.9, 9.1) | 0.67 |
HDL cholesterol, mg/dL | 50.3 (47.9, 52.8) | 50.8 (48.2, 53.4) | -0.43 (-4.04, 3.17) | 0.81 |
Total cholesterol/HDL cholesterol | 2.70 (2.49, 2.91) | 2.73 (2.50, 2.96) | -0.02 (-0.34, 0.29) | 0.87 |
Non-HDL cholesterol | 79.4 (71.7, 87.2) | 81.4 (73.2, 89.6) | -1.97 (-13.2, 9.29) | 0.73 |
Triglycerides, mg/dL | 110. 3 (99.7, 120.9) | 98.1 (86.9, 109.3) | 12.1 (-3.29, 27.6) | 0.12 |
Fasting plasma glucose, mg/dL | 106.5 (103.0, 110.1) | 102.2 (98.5, 105.8) | 4.4 (-0.73, 9.49) | 0.09 |
Insulin, mg/dL | 12.7 (11.5, 13.9) | 11.2 (9.90, 12.5) | 1.53 (-0.25, 3.32) | 0.09 |
HOMA‡ | 3.40 (3.03, 3.77) | 2.87 (2.48, 3.25) | 0.53 (-0.01, 1.07) | 0.05 |
Apolipoprotein-A, mg/dL | 138.6 (128.9, 148.5) | 141.4 (131. 1, 151.7) | -2.74 (-17.0, 11.5) | 0.70 |
Apolipoprotein-B, mg/dL | 71.8 (67.5, 76.1) | 65.9 (61.4, 70.5) | 5.83 (-0.42, 12.1) | 0.07 |
Interleukin-6, pg/mL | 3.34 (2.72, 3.96) | 3.52 (2.86, 4.179 | -0.17 (-1.1, 0.73) | 0.69 |
ICAM-1, ng/mL | 264.7 (227.4, 301.9) | 259.5 (220.3, 298.8) | 5.12 (-49.0, 59.3) | 0.82 |
VCAM-1, ng/mL | 805.9 (743.4, 868.5) | 815.1 (749.2, 881.1) | -9.19 (-100.3, 81.9) | 0.84 |
Oleic acid, umol/mL | 406.2 (355.4, 457.0) | 411.6 (358.1, 465.1) | -5.40 (-79.3, 68.5) | 0.88 |
Weight (kg) | 75.7 (73.2, 78.1) | 75.9 (73.4, 78.5) | -0.29 (-3.83, 3.24) | 0.86 |
Body-mass index, kg/m2 | 26.3 (25.2, 27.3) | 26.2 (25.1, 27.3) | 0.12 (-1.39, 1.65) | 0.87 |
Waist circumference (cm) | 92.7 (90.6, 94.8) | 92.7 (90.4, 94.9) | 0.05 (-2.99, 3.11) | 0.97 |
Waist to hip ratio | 0.93 (0.91, 0.94) | 0.92 (0.91, 0.94) | 0.006 (-0.02, 0.03) | 0.59 |
Waist to height ratio | 0.55 (0.53, 0.56) | 0.55 (0.54, 0.56) | -0.002 (-0.02, 0.01) | 0.77 |
Primary outcome per-protocol population | ||||
LDL cholesterol, mg/dL | 67.2 (60.3, 74.2) | 70.1 (62.6, 77.5) | -2.83 (-13.1, 7.38) | 0.58 |
Primary outcome sensitivity analysis ITT population | ||||
LDL cholesterol, mg/dL | 66.2 (61.7, 70.8) | 70.2 (60.3, 80.2) | -4.0 (-6.8, 14.9) | 0.47 |