Table 4. Composition of participants' diet during the study.
| Variable | Baseline | Final | Change at 12 weeks relative to baseline | Treatment difference | |||
| Mean±SD | Mean±SD | Adjusted least square mean [95%CI] (% change from Baseline) | P | Adjusted least square mean [95%CI] (% difference from placebo) | P | ||
| Total energy intake (Kcal) | Placebo | 1943.26±926.331 | 1814.75±595.81 | -139.11 [-75.24; 353.46] (-7.16%) | 0.200 | 121.79 [-144.74; 388.32] (8.06%) | 0.366 |
| Intervention2 | 1900.05±603.99 | 1927.30±776.01 | 17.15 [-234.35; 200.04] (0.90%) | 0.876 | |||
| Protein (%) | Placebo | 19.03±4.53 | 18.81±4.44 | -0.170 [-0.98; 1.32] (-0.89%) | 0.769 | -1.149 [-2.86; 0.56] (-0.46%) | 0.186 |
| Intervention | 18.02±4.24 | 17.68±3.96 | -0.243 [-0.92; 1.41] (-1.35%) | 0.681 | |||
| Carbohydrates (%) | Placebo | 38.56±7.20 | 37.66±8.11 | -0.862 [-1.68; 3.41] (-2.23%) | 0.503 | 2.143 [1.71; -1.24] (3.02%) | 0.212 |
| Intervention | 39.67±7.67 | 40.18±7.97 | 0.313 [-2.91; 2.28] (0.79%) | 0.811 | |||
| Simple carbohydrates (%) | Placebo | 19.91±6.27 | 18.71±5.56 | -1.220 [-0.57; 3.01] (-6.13%) | 0.178 | 0.557 [1.24; -1.91] (4.05%) | 0.655 |
| Intervention | 19.53±5.88 | 19.51±6.00 | -0.406 [-1.41; 2.22] (-2.08%) | 0.658 | |||
| Complex carbohydrates (%) | Placebo | 18.42±4.82 | 18.83±6.58 | 0.488 [-2.29; 1.31] (2.65%) | 0.591 | 1.59 [-1.00; 4.17] (1.42%) | 0.226 |
| Intervention | 19.95±6.13 | 20.56±6.31 | 0.813 [-2.65; 1.03] (4.07%) | 0.383 | |||
| Lipids (%) | Placebo | 41.47±12.68 | 41.47±9.20 | -0.072 [-3.38; 3.53] (-0.17%) | 0.967 | -1.93 [-5.45; 1.59] (-1.51%) | 0.280 |
| Intervention | 39.96±6.95 | 39.26±7.74 | -0.672 [-2.82; 4.16] (-1.68%) | 0.703 | |||
| MUFA (%) | Placebo | 17.90±3.88 | 20.14±5.94 | 2.193 [-3.93; -0.46] (12.25%) | 0.014 | -1.64 [-3.84; 0.55] (-16.98%) | 0.140 |
| Intervention | 19.26±4.38 | 18.21±4.54 | -0.911 [-0.86; 2.68] (-4.73%) | 0.310 | |||
| PUFA (%) | Placebo | 6.91±6.09 | 5.61±2.67 | -1.334 [-0.50; 3.17] (-19.31%) | 0.151 | 0.76 [-1.23; 2.74] (30.56%) | 0.452 |
| Intervention | 5.67±2.17 | 6.34±6.11 | 0.638 [-2.50; 1.22] (11.25%) | 0.498 | |||
| SFA (%) | Placebo | 10.93±3.00 | 10.60±2.46 | -0.358 [-0.55; 1.26] (-3.27%) | 0.434 | -0.42 [-1.37; 0.53] (-2.12%) | 0.384 |
| Intervention | 10.77±3.15 | 10.16±2.50 | -0.581 [-0.33; 1.49] (-5.39%) | 0.209 | |||
| Cholesterol (mg) | Placebo | 305.73±138.90 | 320.37±148.63 | 12.98 [-57.41; 31.46] (4.25%) | 0.563 | -42.84 [-98.75; 13.07] (1.31%) | 0.131 |
| Intervention | 291.85±127.17 | 277.80±141.24 | -16.23 [-29.03; 61.49] (5.56%) | 0.478 | |||
| Fiber (g) | Placebo | 19.30±8.85 | 16.45±8.05 | -2.809 [-0.33; 5.29] (-14.55%) | 0.027 | 3.48 [0.12; 6.84] (12.51%) | 0.043 |
| Intervention | 20.26±8.48 | 20.12±8.85 | -0.414 [-2.11; 2.94] (-2.04%) | 0.745 | |||
| Alcohol (g) | Placebo | 7.13±12.93 | 7.37±14.19 | 0.350 [-2.97; 2.27] (4.91%) | 0.791 | 0.15 [-4.71; 5.00] (23.36%) | 0.952 |
| Intervention | 5.67±8.30 | 7.57±9.64 | 1.603 [-4.28; 1.08] (28.27%) | 0.238 |
1
Data calculated on the intention-to-treat population (n = 51). Mixed Model for Repeated Measures (MMRM) was used to compare differences between intervention and placebo groups; 2Intervention = AP = Armolipid Plus.