Table 2. Baseline characteristics of subjects in the intention-to-treat and per-protocol populations.
Values are mean±SD; ITT: intention-to-treat; PP: per-protocol; F: female; M: male. The baseline data in the dietary supplement and placebo groups were compared using Student’s t-tests for quantitative variables and Fisher's exact test for sex. No statistically significant difference was found between the two treatment groups in either of the two study populations.
| ITT population | PP population | ||||||
|---|---|---|---|---|---|---|---|
| Placebo | Glycabiane | Changes in Placebo vs. Glycabiane | Placebo (n = 32) | Glycabiane | Changes in Placebo vs. Glycabiane | ||
| Baseline (day 0) | Baseline (day 0) | P value | Baseline (day 0) | Baseline (day 0) | P value | ||
| Dietary control | |||||||
| Energy (kcal/d) | 2037.7 ± 591.4 | 1883.3 ± 703.8 | 0.28 | 1989.5±448.5 | 1883.8±735.9 | 0.38 | |
| Carbohydrates (%) | 41.9 ± 7.1 | 40.9 ± 8.3 | 0.61 | 42.8 ±6.7 | 39.6±7.8 | 0.13 | |
| Protein (%) | 17.6 ± 3.5 | 17.6 ± 3.8 | 0.90 | 17.6±3.6 | 17.7±3.9 | 0.96 | |
| Lipid (%) | 37.5 ± 5.1 | 37.4 ± 5.8 | 0.90 | 37.1±5.5 | 37.9±5.8 | 0.59 | |
| Adiposity markers | |||||||
| Body weight (kg) | 87.6 ± 14.4 | 86.1 ± 9.8 | 0.63 | 87.5±13.7 | 85.8±10.2 | 0.59 | |
| BMI (kg/m2) | 31.6 ± 4.7 | 31.2 ± 3.1 | 0.82 | 31.6 ± 4.5 | 31.4 ± 3.1 | 0.95 | |
| Fat mass (kg) | 33.7 ± 8.7 | 33.5 ± 6.8 | 0.92 | 33.8±9.0 | 34.04±7.1 | 0.92 | |
| Fat mass (%) | 39.00 ± 6.4 | 39.8 ± 7.3 | 0.62 | 39.1±6.8 | 40.6±7.2 | 0.46 | |
| Fat-free mass (kg) | 49.9 ± 9.1 | 48.4 ± 8.9 | 0.52 | 49.6±8.7 | 47.6±8.7 | 0.39 | |
| Fat-free mass (%) | 58.1 ± 6.1 | 57.3 ± 7.0 | 0.60 | 58.0±6.5 | 56.6±6.9 | 0.45 | |
| Adipocyte diameter (μm) | 111.1 ± 9.6 | 114.4 ± 7.2 | 0.14 | 111.3±10.5 | 114.0±7.3 | 0.30 | |
| Lipid Homeostasis | |||||||
| Triacylglycerol (g/L) | 1.3 ± 0.5 | 1.3 ± 0.7 | 0.76 | 1.3±0.5 | 1.3±0.7 | 0.47 | |
| Total cholesterol (g/L) | 2.2± 0.4 | 2.1 ± 0.4 | 0.25 | 2.3±0.5 | 2.1±0.4 | 0,29 | |
| HDL cholesterol (g/L) | 0.5 ± 0.1 | 0.5 ± 0.2 | 0,18 | 0.5±0.1 | 0.6±0.2 | 0,07 | |
| LDL cholesterol (g/L) | 1.5 ± 0.4 | 1.3 ± 0.4 | 0,09 | 1.5±0.4 | 1.4±0.4 | 0,10 | |
| FFA (mmol/L) | 0.4 ± 0.2 | 0.4 ± 0.2 | 0.85 | 0.4±0.2 | 0.5±0.2 | 0.18 | |
| Glucose homeostasis | |||||||
| Fasting Plasma glucose (mmol/L) | 6.0 ± 0.6 | 6.1 ± 0.6 | 0.72 | 6.1±0.6 | 6.1±0.6 | 0,75 | |
| Fasting Plasma insulin (μU/mL) | 9.3 ± 5.4 | 9.9 ± 4.2 | 0.47 | 9.7±5.7 | 9.4±3.5 | 0,86 | |
| HbA1c (%) | 5.9 ± 0.4 | 5.9 ± 0.4 | 0.86 | 5.9±0.4 | 5.9±0.4 | 0,57 | |
| HOMA-IR | 1.3 ± 0.7 | 1.4 ± 0.6 | 0.46 | 1.3±0.8 | 1.3±0.5 | 0,84 | |
| HOMA-S (%) | 101.4 ± 51.5 | 92.2 ± 57.9 | 0.47 | 99.7±54.2 | 95.1±59.3 | 0.84 | |
| HOMA-B (%) | 73.9 ± 24.4 | 76.7 ± 27.2 | 0.68 | 75.0±25.4 | 72.3±17.6 | 0.83 | |
| Revised Quicki | 0.4 ± 0.1 | 0.4 ± 0.04 | 0.48 | 0.4±0.1 | 0.4±0.04 | 0,29 | |
| Disse index | -7.6 ± 6.42 | -6.8 ± 4.8 | 0.62 | -7.7±6.8 | -6.3±4.5 | 0,42 | |
| Adipokines and Inflammatory factors | |||||||
| Leptin (ng/mL) | 30.2 ± 22.9 | 31.0 ± 21.6 | 0.71 | 32.6±24.0 | 32.0±21.9 | 0.82 | |
| Adiponectin (μg/mL) | 5.0 ± 3.4 | 4.5 ± 2.2 | 0.62 | 5.0±3.5 | 4.6±2.1 | 0.96 | |
| hs-CRP(mg/L) | 5.3 ± 6.4 | 4.0 ± 4.3 | 0.49 | 5.9±6.8 | 4.0±4.3 | 0.35 | |
| PAI-1 (ng/mL) | 25.8 ± 21.3 | 26.0 ± 20.4 | 0.75 | 26.5±22.6 | 25.8±20.0 | 0.74 | |
| IL-6 (pg/mL) | 2.0 ± 1.3 | 1.9 ± 1.3 | 0.96 | 1.9±1.3 | 1.9±1.3 | 0.99 | |
| Adipokines explored from adipose tissue | |||||||
| Adiponectin (pg/mL) | 10415.4 ± 10185.4 | 8883.2 ± 6408.2 | 0,87 | 11877±10501 | 9283 ±6581 | 0,51 | |
| IL-6 (pg/mL) | 536.0 ± 420.2 | 1099.2 ± 1699.3 | 0,15 | 576 ± 446 | 1130 ± 1777 | 0,25 | |
| Akt (arbitratry U) | 13.8 ± 14.8 | 11.4 ± 13.8 | 0,49 | 15.2 ± 15.8 | 9.5 ± 11.5 | 0,23 | |