Introduction
Methods
Results
Variable | Diet | Time point (months) |
p valuec
|
p valued
| |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
0 | 6 | 12 | 24 | ||||||||
Value |
p valuea
| Value |
p valueb
| Value |
p valueb
| Value |
p valueb
| ||||
Weight (kg) | LFD | 98.8 ± 21 | 0.15 | 94.2 ± 21 | <0.001 | 94.9 ± 21 | <0.001 | 95.9 ± 21 | 0.002 | <0.001 | 0.33 |
LCD | 91.4 ± 19 | 87.5 ± 19 | <0.001 | 89.5 ± 19 | <0.001 | 89.4 ± 22 | 0.020 | <0.001 | |||
BMI (kg/m2) | LFD | 33.8 ± 5.7 | 0.11 | 32.3 ± 5.5 | <0.001 | 32.6 ± 5.3 | <0.001 | 32.8 ± 5.5 | 0.002 | <0.001 | 0.20 |
LCD | 31.6 ± 5.0 | 30.1 ± 5.1 | <0.001 | 30.7 ± 5.3 | <0.001 | 30.8 ± 5.8 | 0.011 | <0.001 | |||
Waist (cm) | LFD | 110 ± 13 | 0.29 | 106 ± 15 | <0.001 | 106 ± 14 | <0.001 | 108 ± 16 | 0.035 | <0.001 | 0.42 |
LCD | 106 ± 15 | 102 ± 14 | <0.001 | 104 ± 15 | 0.021 | 104 ± 16 | 0.015 | 0.002 | |||
Sagittal abdominal diameter (cm) | LFD | 27 ± 5 | 0.37 | 27 ± 4 | 0.097 | 27 ± 4 | 0.13 | 28 ± 4 | 0.62 | 0.088 | 0.068 |
LCD | 26 ± 4 | 25 ± 4 | 0.006 | 25 ± 4 | 0.006 | 25 ± 4 | 0.014 | 0.002 | |||
HbA1c (%) | LFD | 7.2 ± 2.9 | 0.23 | 7.2 ± 3.0 | 0.56 | 7.3 ± 3.2 | 0.66 | 7.4 ± 3.1 | 0.29 | 0.40 | 0.76 |
LCD | 7.5 ± 3.1 | 7.1 ± 3.1 | 0.004 | 7.3 ± 3.3 | 0.12 | 7.5 ± 3.1 | 0.98 | 0.005 | |||
HbA1c (mmol/mol) | LFD | 55.6 ± 8.0 | 0.23 | 54.7 ± 9.7 | 0.56 | 56.4 ± 11.4 | 0.66 | 57.6 ± 10.8 | 0.29 | 0.40 | 0.76 |
LCD | 58.5 ± 10.2 | 53.7 ± 10.3 | 0.004 | 56.2 ± 12.4 | 0.12 | 58.4 ± 10.6 | 0.98 | 0.005 | |||
Systolic blood pressure (mmHg) | LFD | 136 ± 13 | 0.73 | 128 ± 12 | <0.001 | 126 ± 12 | <0.001 | 125 ± 13 | <0.001 | <0.001 | 0.74 |
LCD | 135 ± 15 | 126 ± 17 | 0.004 | 127 ± 13 | 0.003 | 126 ± 14 | 0.012 | 0.003 | |||
Diastolic blood pressure (mmHg) | LFD | 77 ± 9 | 0.67 | 74 ± 8 | 0.049 | 69 ± 9 | <0.001 | 71 ± 11 | 0.001 | <0.001 | 0.75 |
LCD | 76 ± 11 | 72 ± 8 | 0.019 | 70 ± 10 | 0.002 | 71 ± 8 | 0.004 | 0.002 | |||
Total cholesterol (mmol/l) | LFD | 4.3 ± 1.0 | 0.40 | 4.2 ± 1.1 | 0.91 | 4.3 ± 1.1 | 0.96 | 4.0 ± 0.9 | 0.11 | 0.23 | 0.33 |
LCD | 4.5 ± 1.0 | 4.4 ± 1.1 | 0.60 | 4.3 ± 0.9 | 0.17 | 4.4 ± 0.9 | 0.32 | 0.63 | |||
LDL-cholesterol (mmol/l) | LFD | 2.4 ± 0.7 | 0.24 | 2.3 ± 0.8 | 0.69 | 2.3 ± 0.8 | 0.48 | 2.1 ± 0.7 | 0.017 | 0.050 | 0.16 |
LCD | 2.7 ± 0.9 | 2.5 ± 0.7 | 0.37 | 2.5 ± 0.8 | 0.12 | 2.4 ± 0.7 | 0.020 | 0.13 | |||
HDL-cholesterol (mmol/l) | LFD | 1.09 ± 0.29 | 0.57 | 1.10 ± 0.30 | 0.36 | 1.17 ± 0.24 | 0.004 | 1.20 ± 0.32 | 0.002 | 0.001 | 0.15 |
LCD | 1.13 ± 0.33 | 1.25 ± 0.47 | 0.018 | 1.24 ± 0.38 | 0.024 | 1.36 ± 0.44 | <0.001 | <0.001 | |||
Triacylglycerols (mmol/l) | LFD | 1.8 ± 0.8 | 0.89 | 1.8 ± 1.3 | 0.79 | 1.7 ± 0.9 | 0.88 | 1.7 ± 0.9 | 0.81 | 0.98 | 0.35 |
LCD | 1.7 ± 1.4 | 1.5 ± 1.2 | 0.39 | 1.4 ± 0.8 | 0.20 | 1.5 ± 0.8 | 0.22 | 0.68 | |||
Total insulin dose (E) | LFD | 39 ± 51 | 0.86 | 38 ± 48 | 0.12 | 38 ± 48 | 0.29 | 36 ± 44 | 0.50 | 0.81 | 0.83 |
LCD | 42 ± 65 | 30 ± 47e
| 0.020 | 33 ± 54 | 0.041 | 35 ± 56 | 0.14 | 0.007 | |||
Metformin (mg) | LFD | 1,435 ± 946 | 0.80 | 1,274 ± 884 | 0.096 | 1,371 ± 875 | 0.40 | 1,306 ± 901 | 0.28 | 0.23 | 0.93 |
LCD | 1,375 ± 950 | 1,442 ± 872e
| 0.29 | 1,358 ± 915 | 0.86 | 1,292 ± 911 | 0.38 | 0.39 | |||
Glibenclamide (mg) | LFD | 0.4 ± 1.9 | 0.26 | 0.3 ± 1.3 | 0.33 | 0.3 ± 1.3 | 0.66 | 0.3 ± 1.3 | 0.66 | 0.69 | 0.56 |
LCD | 1.1 ± 2.6 | 0.5 ± 1.3 | 0.057 | 0.5 ± 2.0 | 0.24 | 0.1 ± 0.7 | 0.055 | 0.082 | |||
Simvastatin (mg) | LFD | 19 ± 17 | 1.00 | 19 ± 17 | -f
| 24 ± 17 | 0.032 | 24 ± 17 | 0.032 | 0.003 | 0.54 |
LCD | 19 ± 18 | 23 ± 19 | 0.096 | 28 ± 20 | 0.004 | 27 ± 21 | 0.008 | 0.001 | |||
Atorvastatin (mg) | LFD | 2 ± 5 | 0.97 | 2 ± 6 | 0.33 | 3 ± 9 | 0.18 | 3 ± 9 | 0.18 | 0.24 | 0.88 |
LCD | 2 ± 5 | 2 ± 6 | 0.33 | 2 ± 6 | 0.33 | 2 ± 6 | 0.33 | 0.40 |
Variable | 0 months | 3–6 months | 12 months | 24 months |
p valueb
|
p valuec
| |||
---|---|---|---|---|---|---|---|---|---|
n = 61 |
n = 55 |
n = 42 |
n = 47 | ||||||
Value | Value |
p valuea
| Value |
p valuea
| Value |
p valuea
| |||
Energy intake (kJ) | |||||||||
LFD | 7,569 ± 2,063 | 6,498 ± 1,787 | 0.005 | 6,619 ± 2,075 | 0.075 | 6,104 ± 1,891 | 0.002 | 0.010 | 0.065 |
LCD | 7,071 ± 1,782 | 5,791 ± 1,531 | <0.001 | 6,017 ± 2,075 | 0.037 | 5,234 ± 1,799 | <0.001 | <0.001 | |
Carbohydrate energy (%) | |||||||||
LFD | 48 ± 6 | 49 ± 6 | 0.88 | 47 ± 6 | 0.38 | 47 ± 7 | 0.31 | 0.28 | <0.001 |
LCD | 41 ± 11e
| 25 ± 8d
| <0.001 | 27 ± 8d
| <0.001 | 31 ± 6d
| <0.001 | <0.001 | |
Fat energy (%) | |||||||||
LFD | 32 ± 5 | 29 ± 5 | 0.12 | 31 ± 6 | 0.96 | 31 ± 7 | 0.87 | 0.28 | <0.001 |
LCD | 39 ± 7e
| 49 ± 7d
| <0.001 | 47 ± 6d
| <0.001 | 44 ± 5d
| <0.001 | <0.001 | |
Protein energy (%) | |||||||||
LFD | 19 ± 3 | 21 ± 3 | 0.012 | 20 ± 3 | 0.044 | 20 ± 2 | 0.045 | 0.037 | 0.009 |
LCD | 19 ± 3 | 24 ± 3d
| <0.001 | 23 ± 5d
| 0.002 | 24 ± 4d
| <0.001 | <0.001 | |
Alcohol energy (%) | |||||||||
LFD | 1 ± 2 | 2 ± 3 | 0.23 | 2 ± 3 | 0.36 | 2 ± 3 | 0.27 | 0.72 | 0.49 |
LCD | 2 ± 4 | 2 ± 4 | 0.83 | 2 ± 3 | 0.037 | 2 ± 4 | 0.79 | 0.018 | |
Total fat (g) | |||||||||
LFD | 66 ± 23 | 53 ± 20 | 0.014 | 56 ± 23 | 0.27 | 52 ± 22 | 0.007 | 0.11 | 0.008 |
LCD | 74 ± 23 | 78 ± 24d
| 0.081 | 77 ± 29 | 0.22 | 63 ± 24 | 0.17 | 0.10 | |
Saturated fat energy (%) | |||||||||
LFD | 13 ± 3 | 11 ± 2 | 0.090 | 12 ± 3 | 0.96 | 13 ± 3 | 0.61 | 0.20 | <0.001 |
LCD | 16 ± 4 | 20 ± 4d
| <0.001 | 20 ± 4d
| 0.008 | 19 ± 2d
| <0.001 | <0.001 | |
Unsaturated fat energy (%) | |||||||||
LFD | 12 ± 2 | 11 ± 2 | 0.20 | 11 ± 2 | 0.71 | 11 ± 3 | 0.50 | 0.80 | <0.001 |
LCD | 14 ± 3 | 18 ± 3d
| <0.001 | 17 ± 3d
| <0.001 | 16 ± 3d
| <0.001 | <0.001 | |
Polyunsaturated fat energy (%) | |||||||||
LFD | 5 ± 2 | 5 ± 2 | 0.92 | 5 ± 2 | 0.97 | 5 ± 2 | 0.58 | 0.76 | 0.001 |
LCD | 6 ± 3 | 8 ± 2d
| <0.001 | 8 ± 2d
| 0.006 | 6 ± 2 | 0.044 | 0.002 |
−
4.0 ± 4.1 kg; LCD group −
4.3 ± 3.6 kg; p = 0.75 for difference in change between groups and p < 0.001 within either group; Table 1 and Fig. 2). There were also no statistically significant differences in weight reduction between groups after adjustment for baseline carbohydrate or fat intake (all p > 0.5).
−
3.5 ± 4.0 kg in completers compared with −
2.3 ± 5.1 kg in the total cohort). While sagittal abdominal diameter was stable in the low-fat group, this was reduced by 2 cm in the low-carbohydrate group. However, the low-fat group with energy compliance had reduced systolic and diastolic blood pressure, effects lacking in those randomised to the high-fat diet (Table 3). A second completers analysis based on compliance with fat intake is available in the electronic supplementary material (ESM; compliance defined as: ≤35 E% from fat in the low-fat group, n = 20, or ≥45 E% from fat for the low-carbohydrate group, n = 12, χ
2 between groups for compliance with intake of fat p = 0.06). Similar results to those in the completers analysis according to energy intake were found in this post-hoc calculation for sagittal abdominal diameter and blood pressure. HDL-cholesterol increased from 1.11 ± 0.36 to 1.46 ± 0.59 mmol/l (p = 0.001 for all time points) in those compliant with the LCD according to fat intake, while corresponding figures for the LFD were 1.05 ± 0.26 mmol/l at baseline to 1.17 ± 0.25 mmol/l at 24 months (p = 0.006 within group and p = 0.016 for change between groups).Variable | Diet | Time point (months) |
p valuec
|
p valued
| |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
0 | 6 | 12 | 24 | ||||||||
Value |
p valuea
| Value |
p valueb
| Value |
p valueb
| Value |
p valueb
| ||||
Weight (kg) | LFD | 90.6 ± 19 | 0.66 | 86.7 ± 19 | <0.001 | 88.0 ± 19 | <0.001 | 87.5 ± 19 | 0.008 | <0.001 | 0.75 |
LCD | 88.0 ± 16 | 83.4 ± 15 | <0.001 | 85.6 ± 15 | <0.001 | 84.4 ± 16 | 0.002 | <0.001 | |||
BMI (kg/m2) | LFD | 31.6 ± 5 | 0.71 | 30.2 ± 5 | <0.001 | 30.7 ± 5 | <0.001 | 30.5 ± 5 | 0.005 | <0.001 | 0.74 |
LCD | 31.0 ± 4.5 | 29.4 ± 4.1 | <0.001 | 30.0 ± 4.5 | 0.001 | 29.8 ± 4.5 | 0.002 | <0.001 | |||
Waist (cm) | LFD | 107 ± 13 | 0.31 | 102 ± 15 | <0.001 | 103 ± 16 | <0.001 | 103 ± 16 | 0.004 | <0.001 | 0.57 |
LCD | 103 ± 12 | 100 ± 10 | 0.004 | 100 ± 10 | 0.072 | 100 ± 12 | 0.003 | 0.023 | |||
Sagittal abdominal diameter (cm) | LFD | 26 ± 5 | 0.97 | 25 ± 3 | 0.58 | 26 ± 3 | 0.68 | 26 ± 4 | 0.49 | 0.46 | 0.40 |
LCD | 26 ± 4 | 25 ± 3 | 0.009 | 24 ± 3 | 0.003 | 24 ± 3 | 0.016 | 0.002 | |||
HbA1c (%) | LFD | 7.4 ± 2.8 | 0.83 | 7.3 ± 3.1 | 0.23 | 7.2 ± 2.9 | 0.021 | 7.5 ± 3.1 | 0.69 | 0.19 | 0.73 |
LCD | 7.5 ± 2.8 | 7.0 ± 2.9 | 0.016 | 7.2 ± 3.1 | 0.062 | 7.5 ± 2.9 | 0.94 | 0.026 | |||
HbA1c (mmol/mol) | LFD | 57.9 ± 7.6 | 0.83 | 55.9 ± 9.9 | 0.23 | 55.5 ± 8.0 | 0.021 | 58.5 ± 10.4 | 0.69 | 0.19 | 0.73 |
LCD | 58.4 ± 7.5 | 52.8 ± 8.3 | 0.016 | 54.8 ± 10.1 | 0.062 | 58.3 ± 8.7 | 0.94 | 0.026 | |||
Systolic blood pressure (mmHg) | LFD | 134 ± 11 | 0.73 | 129 ± 13 | 0.078 | 127 ± 12 | 0.022 | 123 ± 10 | 0.005 | 0.007 | 0.73 |
LCD | 133 ± 13 | 125 ± 16 | 0.053 | 127 ± 13 | 0.085 | 126 ± 14 | 0.195 | 0.13 | |||
Diastolic blood pressure (mmHg) | LFD | 74 ± 10 | 0.91 | 74 ± 8 | 0.84 | 68 ± 9 | 0.035 | 70 ± 8 | 0.032 | 0.012 | 0.80 |
LCD | 74 ± 11 | 71 ± 8 | 0.17 | 71 ± 11 | 0.16 | 71 ± 8 | 0.11 | 0.22 | |||
Total cholesterol (mmol/l) | LFD | 4.0 ± 0.7 | 0.078 | 4.1 ± 0.9 | 0.67 | 4.0 ± 0.7 | 0.66 | 3.9 ± 0.8 | 0.57 | 0.73 | 0.11 |
LCD | 4.5 ± 1.0 | 4.4 ± 1.3 | 0.65 | 4.4 ± 0.9 | 0.34 | 4.4 ± 1.0 | 0.67 | 0.90 | |||
LDL-cholesterol (mmol/l) | LFD | 2.2 ± 0.4 | 0.043 | 2.2 ± 0.7 | 0.84 | 2.2 ± 0.6 | 0.91 | 2.0 ± 0.7 | 0.16 | 0.43 | 0.13 |
LCD | 2.7 ± 0.9 | 2.5 ± 0.9 | 0.37 | 2.5 ± 0.7 | 0.10 | 2.4 ± 0.8 | 0.066 | 0.34 | |||
HDL-cholesterol (mmol/l) | LFD | 1.14 ± 0.32 | 0.94 | 1.18 ± 0.32 | 0.28 | 1.21 ± 0.26 | 0.029 | 1.26 ± 0.34 | 0.050 | 0.080 | 0.67 |
LCD | 1.15 ± 0.36 | 1.26 ± 0.48 | 0.034 | 1.23 ± 0.38 | 0.017 | 1.37 ± 0.46 | <0.001 | <0.001 | |||
Triacylglycerols (mmol/l) | LFD | 1.5 ± 0.7 | 0.88 | 1.4 ± 0.7 | 0.67 | 1.4 ± 0.7 | 0.17 | 1.6 ± 1.0 | 0.52 | 0.49 | 0.91 |
LCD | 1.4 ± 0.6 | 1.4 ± 1.1 | 0.97 | 1.4 ± 0.5 | 0.84 | 1.5 ± 0.8 | 0.56 | 0.96 | |||
Total insulin dose (E) | LFD | 32 ± 41 | 0.73 | 30 ± 37 | 0.34 | 31 ± 38 | 0.73 | 30 ± 40 | 0.68 | 0.92 | 0.38 |
LCD | 26 ± 54 | 14 ± 28 | 0.13 | 16 ± 33 | 0.16 | 20 ± 37 | 0.34 | 0.12 | |||
Metformin (mg) | LFD | 1,353 ± 981 | 0.81 | 1,176 ± 865 | 0.27 | 1,324 ± 847 | 0.79 | 1,265 ± 903 | 0.65 | 0.58 | 0.90 |
LCD | 1,278 ± 844 | 1,444 ± 784 | 0.055 | 1,306 ± 860 | 0.85 | 1,222 ± 826 | 0.71 | 0.37 | |||
Glibenclamide (mg) | LFD | 0.7 ± 2.6 | 0.45 | 0.5 ± 1.7 | 0.33 | 0.6 ± 1.7 | 0.67 | 0.6 ± 1.7 | 0.67 | 0.69 | 1.0 |
LCD | 1.5 ± 3.1 | 0.5 ± 1.2 | 0.056 | 0.3 ± 0.9 | 0.083 | 0.2 ± 0.8 | 0.099 | 0.039 | |||
Simvastatin (mg) | LFD | 21 ± 17 | 0.64 | 21 ± 17 | –e
| 25 ± 17 | 0.19 | 25 ± 17 | 0.19 | 0.14 | 0.95 |
LCD | 18 ± 19 | 23 ± 19 | 0.16 | 26 ± 23 | 0.049 | 26 ± 23 | 0.049 | 0.025 | |||
Atorvastatin (mg) | LFD | 1 ± 2 | 0.21 | 1 ± 5 | 0.33 | 1 ± 5 | 0.33 | 1 ± 5 | 0.33 | 0.40 | 0.30 |
LCD | 3 ± 7 | 3 ± 8 | 0.33 | 3 ± 8 | 0.33 | 3 ± 8 | 0.33 | 0.40 |