Table 2.
Changes in dietary intake, clinical and laboratory variables during the study. Data are means ± SD. Listed p-values are for interactions between group and time assessed by repeated measures ANOVA. * p < 0.05, ** p < 0.01 and *** p < 0.001 for within-group changes from baseline assessed by paired comparison t-tests.
| Control Group | Intervention Group | Treatment Effect | p-Value | |||
|---|---|---|---|---|---|---|
| Baseline | Week 16 | Baseline | Week 16 | |||
| Total physical activity (METs) | 2642 (1476–3809) | 2575 (1169–3980) | 2207 (1444–2969) | 2490 (1586–3395) | +351 (−1143 to +1846) | 0.46 |
| Dietary intake | ||||||
| Caloric intake (kcal/day) | 1923 (1627–2219) | 1582 (1368–1795) ** | 1851 (1695–2007) | 1450 (1249–1652) *** | −60 (−352 to +233) | 0.69 |
| Carbohydrates (% of daily energy) | 45.5 (42.6–48.4) | 46.6 (42.9–50.4) | 46.1 (43.5–48.8) | 69.6 (67.3–71.8) *** | +22.3 (+17.7 to +26.9) | <0.001 |
| Fats (% of daily energy) | 35.6 (32.3–38.9) | 35.0 (31.5–38.4) | 36.1 (34.0–38.1) | 17.5 (15.5–19.4) *** | −17.9 (−22.3 to −13.6) | <0.001 |
| Proteins (% of daily energy) | 16.1 (15.0–17.1) | 17.0 (15.5–18.5) | 16.8 (15.4–18.2) | 12.3 (11.3–13.3) *** | −5.4 (−7.8 to −3.0) | <0.001 |
| Fiber intake (g/day) | 25.2 (20.9–29.6) | 23.5 (19.6–27.4) | 24.2 (21.0–27.4) | 37.8 (31.4–44.1) *** | +15.3 (+8.0 to +22.6) | <0.001 |
| Cholesterol intake (mg/day) | 290 (220–360) | 212 (149–275) | 264 (213–315) | 6.5 (2.5–10.5) *** | −180 (−278 to −82) | <0.001 |
| Saturated fatty acids (g/day) | 25.5 (19.8–31.1) | 17.9 (13.6–22.2) ** | 24.5 (21.2–27.7) | 5.6 (4.6–6.7) *** | −11.2 (−16.5 to −5.9) | <0.001 |
| Monounsaturated fatty acids (g/day) | 30.5 (23.8–37.2) | 24.9 (19.8–30.0) | 28.9 (25.1–32.7) | 9.5 (7.8–11.2) *** | −13.8 (−19.5 to −8.2) | <0.001 |
| Polyunsaturated fatty acids (g/day) | 20.9 (15.3–26.5) | 17.9 (14.8–21.1) | 18.2 (15.2–21.1) | 10.6 (9.0–12.2) *** | −4.6 (−10.1 to +0.9) | 0.10 |
| Glycemic index | 58.1 (56.2–59.9) | 57.4 (55.3–59.5) * | 57.7 (55.5–59.9) | 54.4 (53.4–55.5) ** | −2.6 (−5.7 to +0.5) | 0.10 |
| Anthropometric variables | ||||||
| BMI (kg/m2) | 33.6 (32.5–34.8) | 33.4 (32.2–34.6) | 33.1 (31.8–34.3) | 31.2 (29.9–32.5) *** | −2.0 (−2.6 to −1.5) | <0.001 |
| Lean mass (kg) | 49.8 (46.2–53.4) | 48.8 (45.4–52.2) ** | 50.6 (48.6–52.5) | 48.3 (46.5–50.1) *** | −1.2 (−2.0 to −0.5) | 0.002 |
| Fat mass (kg) | 39.1 (35.6–42.5) | 39.5 (36.0–43.0) | 42.0 (39.3–44.7) | 38.1 (35.6–40.7) *** | −4.3 (−5.4 to −3.2) | <0.001 |
| Visceral fat volume (cm3) | 1434 (1154–1714) | 1459 (1173–1744) | 1289 (1040–1539) | 1090 (864–1315) *** | −224 (−328 to −120) | <0.001 |
| Laboratory variables | ||||||
| Total cholesterol (mmol/L) | 5.4 (5.0–5.8) | 5.3 (5.0–5.6) | 5.4 (5.1–5.7) | 4.8 (4.4–5.2) *** | −1.1 (−2.0 to −0.2) | 0.02 |
| HDL-cholesterol (mmol/L) | 1.6 (1.4–1.8) | 1.6 (1.4–1.8) | 1.6 (1.5–1.8) | 1.4 (1.3–1.6) *** | −0.4 (−0.6 to −0.2) | 0.002 |
| LDL-cholesterol (mmol/L) | 3.2 (2.9–3.6) | 3.2 (2.9–3.5) | 3.2 (2.9–3.5) | 2.7 (2.3–3.1) ** | −0.9 (−1.8 to −0.1) | 0.03 |
| Triglycerides (mmol/L) | 1.1 (0.9–1.4) | 1.2 (0.9–1.6) | 1.2 (1.0–1.3) | 1.4 (1.2–1.7) ** | +0.9 (−0.3 to +2.2) | 0.16 |
| Fasting plasma glucose (mmol/L) | 5.5 (5.3–5.7) | 5.6 (5.4–5.8) | 5.3 (5.1–5.6) | 5.1 (4.9–5.2) ** | −0.4 (−0.6 to −0.2) | <0.001 |
| Fasting plasma insulin (pmol/L) | 72.9 (56.9–88.2) | 88.9 (38.9–135.4) | 91.7 (72.9–111.8) | 71.5 (55.6–87.5) ** | −85.4 (−170.8 to +0.7) | 0.05 |
| Fasting plasma C-peptide (ng/mL) | 2.5 (2.2–2.8) | 3.0 (2.2–3.8) | 2.6 (2.3–2.9) | 2.1 (1.9–2.4) *** | −1.0 (−1.6 to −0.4) | 0.003 |
| HbA1c (DCCT, %) | 5.8 (5.7–5.9) | 5.8 (5.7–5.9) | 5.8 (5.7–5.9) | 5.8 (5.7–5.9) | 0.0 (−0.1 to +0.1) | 0.81 |
| HbA1c (IFCC, mmol/mol) | 40 (38.8–41.2) | 40.1 (38.8–41.4) | 39.9 (38.3–41.4) | 40.1 (38.9–41.4) | +0.1 (−24.6 to +22.4) | 0.81 |
| Insulin secretion/ Beta-cell function | ||||||
| Basal insulin secretion (pmol/min/m2) | 100.5 (94.4–107.2) | 104.1 (97.7–111.3) | 108.6 (102.2–115.8) | 83.0 (78.9–87.5) ** | −54.2 (−86.5 to −21.9) | <0.001 |
| Total insulin secretion (nmol/m2) | 55.3 (52.6–58.2) | 63.3 (60.4–66.4) ** | 53.8 (51.4–56.3) | 54.8 (52.4–57.3) | −8.8 (−17.3 to +0.4) | 0.07 |
| Insulin secretion at a fixed glucose value (5 mM) (pmol/min/m2) | 110.0 (99.6–121.1) | 103.1 (93.9–112.8) | 109.4 (100.1–119.4) | 116.6 (105.9–128.1) * | +14.2 (−25.0 to +63.3) | 0.10 |
| Mean glucose (mmol/L) | 5.5 (5.2–5.8) | 6.1 (5.7–6.4) *** | 5.6 (5.2–6.0) | 5.4 (4.9–5.9) * | −0.8 (−1.2 to −0.4) | <0.001 |
| Mean insulin (pmol/L) | 312.2 (234.4–390.0) | 406.4 (316.8–496.0) * | 330.0 (259.4–400.6) | 348.6 (274.7–422.5) | −75.7 (−180.4 to +29.1) | 0.15 |
| Glucose sensitivity (pmol/min/m2/mM) | 107.5 (76.4–146.5) | 181.1 (135.3–237.2) | 108.5 (80.8–142.4) | 213.8 (167.9–268.3) ** | +65.5 (−74.4 to +205.4) | 0.13 |
| Rate sensitivity (pmol/m2/mM) | 2260 (1419–3101) | 1978 (1188–2768) | 2783 (2127–3438) | 2269 (1505–3033) | −232 (−1601 to +1137) | 0.38 |
| Potentiation factor ratio (dimensionless) | 1.45 (1.28–1.63) | 1.62 (1.43–1.82) | 1.32 (1.17–1.47) | 1.08 (0.95–1.22) | −0.51 (−1.04 to +0.03) | 0.08 |
| Insulin sensitivity /resistance | ||||||
| 3 h-oral glucose insulin sensitivity (mL/min/m2) | 403.2 (389.1–417.6) | 388.2 (374.5–402.3) | 404.1 (391.7–416.8) | 406.7 (394.2–419.5) | +10.8 (−29.5 to +51.1) | 0.78 |
| HOMA-IR (dimensionless) | 2.4 (2.1–2.7) | 2.8 (2.5–3.1) | 2.5 (2.3–2.8) | 1.9 (1.7–2.1) *** | −1.0 (−1.2 to −0.8) | 0.004 |