Table 2.
Changes in clinical parameters and differences between P-FD group and F-FD group.
| P-FD (Protein: Fat: Carbohydrate = 21:23:56) | F-FD (Protein: Fat: Carbohydrate = 16:29:55) | P-FD vs F-FD | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 | Week 24 | Change in value Week 24–Week 0 | P | Week 0 | Week 24 | Change in value Week 24–Week 0 | P | P | |||||||
| HbA1c (%) | 7.4 | (7.3 to 7.5) | 6.7 | (6.5 to 6.8) | − 0.7 | (− 0.9 to − 0.5) | < 0.0001 | 7.4 | (7.3 to 7.5) | 6.8 | (6.6 to 6.9) | − 0.6 | (− 0.8 to − 0.5) | < 0.0001 | 0.4474 |
| HbA1c (mmol/mol) | 57.2 | (56.1 to 58.4) | 49.5 | (47.8 to 51.3) | − 7.6 | (− 9.4 to − 5.9) | < 0.0001 | 57.1 | (55.8 to 58.4) | 50.5 | (48.8 to 52.1) | − 6.8 | (− 8.2 to − 5.3) | < 0.0001 | 0.4474 |
| Fasting glucose (mmol/l) | 8.2 | (7.7 to 8.6) | 7.1 | (6.5 to 7.7) | − 1.1 | (− 1.8 to − 0.5) | 0.0009 | 8.2 | (7.7 to 8.7) | 7.2 | (6.8 to 7.5) | − 1.1 | (− 1.5 to − 0.7) | < 0.0001 | 0.9614 |
| Body weight (kg) | 77.0 | (73.8 to 80.2) | 74.1 | (70.6 to 77.5) | − 3.5 | (− 4.3 to − 2.8) | < 0.0001 | 76.6 | (72.2 to 81.0) | 73.6 | (69.1 to 78.2) | − 2.9 | (− 3.6 to − 2.3) | < 0.0001 | 0.2611 |
| BMI (kg/m2) | 29.4 | (28.3 to 30.45) | 28.1 | (26.9 to 29.3) | − 1.4 | (− 1.7 to − 1.1) | < 0.0001 | 29.8 | (28.2 to 31.4) | 28.6 | (27.0 to 30.2) | − 1.2 | (− 1.4 to − 0.9) | < 0.0001 | 0.3295 |
| Waist circumference (cm) | 100.4 | (97.6 to 103.2) | 95.7 | (92.5 to 98.8) | − 4.4 | (− 6.5 to − 2.3) | 0.0001 | 99.1 | (96.2 to 102.1) | 95.8 | (92.4 to 99.2) | − 3.1 | (− 4.2 to − 2.0) | < 0.0001 | 0.2743 |
| sBP (mmHg) | 133.2 | (129.0 to 137.4) | 130.2 | (126.8 to 133.5) | − 3.1 | (− 7.0 to 0.8) | 0.1166 | 133.9 | (130.5 to 137.3) | 130.1 | (127.0 to 133.2) | − 3.9 | (− 7.6 to − 0.3) | 0.0348 | 0.7606 |
| dBP (mmHg) | 80.2 | (77.5 to 82.9) | 79.2 | (76.5 to 81.9) | − 1.0 | (− 3.3 to 1.3) | 0.3727 | 79.1 | (76.9 to 81.4) | 79.0 | (76.7 to 81.3) | − 0.3 | (− 2.8 to 2.2) | 0.8194 | 0.6646 |
| Heart rate (bpm) | 77.5 | (74.0 to 81.1) | 77.6 | (74.0 to 81.3) | − 0.4 | (− 2.9 to 2.2) | 0.7747 | 78.0 | (74.3 to 81.6) | 79.7 | (75.9 to 83.4) | 1.5 | (− 1.7 to 4.7) | 0.3608 | 0.3697 |
| Fasting insulin (μIU/ml) | 13.0 | (8.2 to 17.9) | 7.74 | (6.53 to 8.95) | − 5.8 | (− 10.7 to − 0.8) | 0.0232 | 12.1 | (9.0 to 15.2) | 13.5 | (8.1 to 18.9) | 1.5 | (− 2.9 to 5.7) | 0.5077 | 0.0299 |
| HOMA-IR | 5.3 | (2.9 to 7.7) | 2.4 | (2.0 to 2.8) | − 3.1 | (− 5.7 to − 0.6) | 0.0176 | 5.0 | (2.7 to 7.3) | 4.5 | (2.5 to 6.6) | − 0.5 | (− 2.8 to 1.8) | 0.6720 | 0.1279 |
| HOMA-beta (%) | 54.5 | (39.8 to 69.2) | 53.0 | (42.5 to 63.5) | − 3.23 | (− 13.6 to 7.2) | 0.5366 | 55.6 | (44.0 to 67.2) | 82.7 | (52.2 to 113.1) | 27.2 | (3.4 to 50.9) | 0.0257 | 0.0214 |
| Total cholesterol (mmol/l) | 5.0 | (4.7 to 5.2) | 5.2 | (4.9 to 5.4) | 0.2 | (− 0.0 to 0.3) | 0.0765 | 5.1 | (4.9 to 5.4) | 5.3 | (5.0 to 5.5) | 0.1 | (− 0.1 to 0.3) | 0.2304 | 0.7917 |
| Triglyceride (mmol/l) | 1.6 | (1.4 to 1.9) | 1.5 | (1.2 to 1.7) | − 0.2 | (− 0.4 to 0.1) | 0.1298 | 1.8 | (1.5 to 2.1) | 1.6 | (1.4 to 1.8) | − 0.2 | (− 0.4 to − 0.0) | 0.0297 | 0.7896 |
| LDL-cholesterol (mmol/l) | 3.0 | (2.7 to 3.2) | 3.0 | (2.8 to 3.3) | 0.0 | (− 0.1 to 0.2) | 0.7453 | 3.1 | (3.0 to 3.4) | 3.2 | (3.0 to 3.4) | 0.1 | (− 0.1 to 0.2) | 0.5048 | 0.7880 |
| HDL-cholesterol (mmol/l) | 1.3 | (1.3 to 1.4) | 1.5 | (1.4 to 1.6) | 0.2 | (0.1 to 0.3) | < 0.0001 | 1.3 | (1.3 to 1.4) | 1.4 | (1.3 to 1.5) | 0.1 | (0.1 to 0.2) | < 0.0001 | 0.0143 |
| Skeletal muscle mass (kg) | 26.8 | (25.3 to 28.2) | 26.3 | (25.0 to 27.7) | − 0.7 | (− 0.9 to − 0.5) | < 0.0001 | 26.5 | (24.9 to 28.2) | 25.7 | (24.1 to 27.4) | − 0.7 | (− 1.0 to − 0.5) | < 0.0001 | 0.8793 |
| Body fat mass (kg) | 28.6 | (26.7 to 30.6) | 26.5 | (24.1 to 28.9) | − 2.6 | (− 3.3 to − 2.0) | < 0.0001 | 29.1 | (26.2 to 32.1) | 27.4 | (24.4 to 30.5) | − 1.5 | (− 2.3 to − 0.8) | 0.0002 | 0.0290 |
| AST (IU/l) | 30.2 | (26.0 to 34.5) | 24.6 | (22.3 to 26.9) | − 5.9 | (− 9.1 to − 2.6) | 0.0007 | 27.7 | (24.9 to 30.5) | 26.4 | (23.1 to 29.6) | − 1.5 | (− 4.5 to 1.4) | 0.3049 | 0.0513 |
| ALT (IU/l) | 40.2 | (31.8 to 48.6) | 30.4 | (25.3 to 35.5) | − 10.9 | (− 16.6 to − 5.1) | 0.0004 | 35.8 | (31.4 to 40.3) | 31.2 | (26.6 to 35.9) | − 5.0 | (− 9.0 to − 1.1) | 0.0138 | 0.1000 |
| γ-GTP (IU/l) | 51.3 | (39.5 to 63.1) | 39.6 | (31.9 to 47.2) | − 13.9 | (− 20.8 to − 6.9) | 0.0002 | 53.4 | (39.4 to 67.4) | 39.3 | (29.7 to 48.9) | − 14.3 | (− 21.0 to − 7.6) | 0.0001 | 0.9300 |
| Uric acid (mg/dl) | 5.3 | (4.9 to 5.6) | 4.7 | (4.4 to 5.0) | − 0.6 | (− 0.9 to − 0.4) | < 0.0001 | 5.3 | (5.0 to 5.6) | 4.8 | (4.5 to 5.1) | − 0.5 | (− 0.7 to − 0.3) | < 0.0001 | 0.4471 |
| BUN (mg/dl) | 13.3 | (12.4 to 14.2) | 16.7 | (15.5 to 17.8) | 3.3 | (2.2 to 4.3) | < 0.0001 | 13.5 | (12.6 to 14.4) | 15.0 | (14.2 to 15.8) | 1.7 | (1.0 to 2.4) | < 0.0001 | 0.0112 |
| Creatinine (mg/dl) | 0.66 | (0.62 to 0.70) | 0.69 | (0.64 to 0.73) | 0.02 | (0.01 to 0.04) | 0.0139 | 0.66 | (0.62 to 0.70) | 0.68 | (0.64 to 0.73) | 0.03 | (0.01 to 0.04) | 0.0002 | 0.9319 |
| eGFR (mL/min/1.73m2) | 85.6 | (80.9 to 90.3) | 82.8 | (77.8 to 87.9) | − 3.2 | (− 5.8 to − 0.5) | 0.0202 | 85.9 | (80.0 to 91.7) | 83.1 | (76.7 to 89.4) | − 3.3 | (− 5.4 to − 1.2) | 0.0031 | 0.9433 |
| Urinary albumin (mg/g Cr) | 93.9 | (− 5.7 to 193.4) | 91.6 | (5.5 to 177.7) | − 10.7 | (− 50.7 to 29.4) | 0.5963 | 69.3 | (39.5 to 99.1) | 78.9 | (34.0 to 123.8) | − 3.0 | (− 37.7 to 31.7) | 0.8635 | 0.7727 |
| Total ketone body (μmol/l) | 134.1 | (103.84 to 164.4) | 209.3 | (143.5 to 275.1) | 76.5 | (10.8 to 142.2) | 0.0234 | 121.8 | (87.0 to 156.6) | 171.0 | (118.1 to 224.0) | 48.1 | (8.7 to 87.5) | 0.0175 | 0.4602 |
| Acetoacetic acid (μmol/l) | 44.0 | (34.8 to 53.2) | 61.7 | (46.1 to 77.4) | 19.2 | (3.9 to 34.5) | 0.0149 | 39.8 | (31.1 to 48.5) | 53.5 | (40.0 to 67.0) | 13.5 | (3.8 to 23.3) | 0.0075 | 0.5335 |
| 3-hydroxybutyric acid (μmol/l) | 90.8 | (69.0 to 112.6) | 147.6 | (96.9 to 198.3) | 57.3 | (6.2 to 108.5) | 0.0287 | 82.0 | (55.7 to 108.3) | 117.5 | (77.9 to 157.2) | 34.5 | (4.6 to 64.4) | 0.0246 | 0.4429 |
| hs-CRP (mg/dl) | 0.17 | (0.13 to 0.21) | 0.14 | (0.10 to 0.18) | − 0.02 | (− 0.06 to 0.01) | 0.1675 | 0.15 | (0.12 to 0.18) | 0.18 | (0.14 to 0.22) | 0.03 | (− 0.01 to 0.07) | 0.1262 | 0.0391 |
P-FD protein-rich formula diet, F-FD fat-rich formula diet, BMI body fat mass, sBP systolic blood pressure; diastolic blood pressure, HOMA-IR homeostasis model assessment of insulin resistance, LDL low density lipoprotein, HDL high density lipoprotein, AST aspartate aminotransferase, ALT alanine aminotransferase, γ-GTP gamma-glutamyl transpeptidase, BUN blood urea nitrogen, eGFR estimated glomerular filtration rate, hs-CRP high-sensitivity C-reactive protein. Data are expressed in mean (95% CI).