TABLE 2.
Changes in anthropometric and metabolic parameters between baseline and month 6 a
| Placebo (n = 13) | TOTUM‐63 (n = 38) | Intervention effects | |||||
|---|---|---|---|---|---|---|---|
| Baseline | 6 months | Baseline | 6 months | Placebo change | TOTUM‐63 change | p value | |
| Body weight, kg | 89.5 ± 15.1 | 91.4 ± 15.5 | 85.0 ± 16.5 | 84.9 ± 16.7 | 1.83 ± 2.05 | −0.07 ± 2.58 | .02 |
| Body mass index, kg/m2 | 33.3 ± 6.1 | 33.9 ± 6.2 | 30.6 ± 5.0 | 30.6 ± 5.2 | 0.7 ± 0.7 | −0.01 ± 0.9 | .01 |
| Waist circumference, cm | 103.9 ± 11.0 | 106.7 ± 11.3 | 103.6 ± 12.2 | 101.9 ± 12.9 | 2.8 ± 2.34 | −1.7 ± 4.51 | .001 |
| Hip circumference, cm | 113.0 ± 13.2 | 113.8 ± 13.9 | 107.0 ± 9.6 | 107.1 ± 9.6 | 0.8 ± 3.0 | 0.1 ± 4.2 | .62 |
| Fasting plasma glucose, mmol/L | 6.99 ± 1.49 | 7.47 ± 1.62 | 6.89 ± 1.14 | 6.66 ± 0.83 | 0.48 ± 0.90 | −0.24 ± 1.04 | .026 |
| Fasting insulinaemia, mU/L | 21.2 ± 19.5 | 18.6 ± 13.5 | 21.0 ± 13.6 | 18.8 ± 10.8 | −2.7 ± 8.0 | −2.1 ± 14.0 | .76 |
| HOMA‐IR score | 7.41 ± 9.21 | 6.45 ± 5.81 | 6.50 ± 4.65 | 5.54 ± 3.18 | −0.96 ± 3.85 | −0.97 ± 5.10 | .42 |
| HbA1c, % | 6.23 ± 0.46 | 6.40 ± 0.67 | 5.92 ± 0.51 | 5.93 ± 0.57 | 0.17 ± 0.37 | 0.01 ± 0.34 | .20 |
| 2‐h OGTT glycaemia, mmol/L | 10.77 ± 2.45 | 12.53 ± 3.44 | 10.13 ± 3.17 | 10.01 ± 3.07 | 1.81 ± 3.58 | −0.12 ± 2.53 | .049 |
| Triglycerides, mmol/L | 1.66 ± 0.73 | 1.83 ± 0.68 | 2.11 ± 0.93 | 1.75 ± 0.97 | 0.18 ± 0.62 | −0.36 ± 0.72 | .008 |
| Total cholesterol, mmol/L | 5.24 ± 1.07 | 5.57 ± 1.21 | 5.58 ± 0.92 | 5.31 ± 0.87 | 0.33 ± 0.93 | −0.27 ± 0.78 | .02 |
| LDL‐cholesterol, mmol/L | 3.22 ± 0.92 | 3.43 ± 0.93 | 3.46 ± 0.78 | 3.28 ± 0.70 | 0.21 ± 0.65 | −0.17 ± 0.65 | .04 |
| HDL‐cholesterol, mmol/L | 1.24 ± 0.24 | 1.29 ± 0.29 | 1.15 ± 0.36 | 1.21 ± 0.33 | 0.05 ± 0.20 | 0.06 ± 0.16 | .59 |
| NEFA, mmol/L | 0.49 ± 0.20 | 0.47 ± 0.20 | 0.56 ± 0.20 | 0.46 ± 0.18 | −0.02 ± 0.19 | −0.10 ± 0.23 | .30 |
| Systolic blood pressure, mmHg | 131.9 ± 12.2 | 139.5 ± 20.4 | 130.8 ± 14.1 | 127.7 ± 12.4 | 7.5 ± 11.9 | −3.0 ± 10.2 | .004 |
| Diastolic blood pressure, mmHg | 82.3 ± 15.2 | 84.2 ± 11.6 | 82.3 ± 9.3 | 80.6 ± 7.4 | 1.8 ± 7.1 | −1.7 ± 9.0 | .12 |
a
Values are the mean ± SD. Statistical analyses were performed with linear mixed models and baseline values as the adjustment covariate.
Abbreviations: HbA1c, glycated haemoglobin; HDL, high‐density lipoprotein; LDL, low‐density lipoprotein; NFEA, non‐esterified fatty acids; OGTT, oral glucose tolerance test.