Baseline characteristics of the DIRECT PLUS participants*
| Entire (n=294) | HDG (n=98) | MED (n=98) | Green-MED (n=98) | P value between groups† | |
| IHF content, %‡ | 6.6 (3.5, 15.1) | 7.0 (3.4, 15.1) | 5.9 (3.8, 14.9) | 7.7 (3.1, 17.8) | 0.62 |
| NAFLD (IHF>5%), %‡ | 62 | 63 | 60 | 62 | 0.88 |
| Obese§, % | 58.8 | 60.2 | 59.2 | 57.1 | 0.91 |
| Diabetic¶, % | 10.9 | 10.3 | 9.3 | 13.3 | 0.65 |
| Anthropometric | |||||
| Age, years | 51.1±10.5 | 51.10±10.6 | 51.68±10.4 | 50.55±10.8 | 0.76 |
| Men, number (%) | 259 (88.1) | 86 (87.8) | 86 (87.8) | 87 (88.8) | 0.97 |
| BMI, kg/m2† | 31.3±4.0 | 31.2±3.8 | 31.3±4.0 | 31.3±4.2 | 0.99 |
| Weight, kg | 93.7±14.3 | 92.9±14.7 | 94.5±13.5 | 93.6±14.9 | 0.73 |
| Waist circumference, cm | 109.7±9.5 | 109.9±10.3 | 110.0±9.5 | 109.3±8.7 | 0.86 |
| Men | 110.6±9.1 | 110.7±10.1 | 110.7±9.3 | 110.4±8.0 | 0.97 |
| Women | 103.3±9.6 | 103.8±9.7 | 105.2±9.6 | 100.8±9.9 | 0.56 |
| Diastolic-BP, mm Hg | 81.1±10.2 | 80.2±11.3 | 81.7±8.8 | 81.3±10.4 | 0.53 |
| Systolic-BP, mm Hg | 130.3±14.0 | 130.2±14.3 | 130.1±12.5 | 130.4±15.2 | 0.99 |
| Blood biomarkers | |||||
| HDL, mg/dL | 46.0±11.7 | 45.4±11.5 | 47.1±11.1 | 45.4±12.4 | 0.51 |
| Men | 44.3±10.2 | 43.4±9.9 | 46.1±10.1 | 43.3±10.7 | 0.13 |
| Women | 58.6±13.9 | 59.6±12.6 | 54.4±15.7 | 62.0±13.4 | 0.42 |
| LDL, mg/dL | 125.7±30.1 | 126.8±32.3 | 127.0±31.0 | 123.3±29.2 | 0.64 |
| TG/HDL ratio** | 3.0 (2.0, 4.5) | 3.1 (2.0, 4.8) | 2.9 (2.0, 4.6) | 2.9 (2.0, 4.3) | 0.53 |
| Cholesterol/HDL ratio | 4.4±1.3 | 4.4±1.2 | 4.3±1.3 | 4.4±1.4 | 0.82 |
| Fasting glucose, mg/dL** | 98.4 (92.3, 106.3) | 98.4 (91.9, 105.4) | 98.1 (92.4, 106.3) | 98.9 (92.4, 107.8) | 0.86 |
| Insulin, µU/mL** | 13.0 (9.7, 18.9) | 13.0 (9.7, 18.9) | 13.3 (10.2, 17.8) | 12.9 (9.3, 18.1) | 0.33 |
| HOMA IR** | 3.2 (2.3, 4.6) | 3.1 (2.2, 4.9) | 3.2 (2.5, 4.4) | 3.2 (2.2, 4.5) | 0.53 |
| hsCRP, mg/L** | 2.5 (1.5, 4.2) | 2.3 (1.3, 4.4) | 2.6 (1.6, 4.3) | 2.4 (1.3, 4.2) | 0.58 |
| Liver enzymes and adipokines | |||||
| ALT, U/L | 34.9±16.8 | 34.9±20.1 | 33.1±12.5 | 35.7±16.8 | 0.56 |
| AST, U/L | 25.6±7.7 | 25.9±8.6 | 25.2±6.5 | 25.8±7.9 | 0.91 |
| ALT/AST ratio | 1.3±0.4 | 1.4±0.4 | 1.3±0.4 | 1.4±0.4 | 0.60 |
| ALKP, mg/dL | 74.2±19.3 | 73.7±17.3 | 73.4±18.2 | 75.4±22.1 | 0.98 |
| Chemerin, ng/mL | 207.9±43.5 | 205.9±44.1 | 208.5±43.6 | 209.4±43.1 | 0.81 |
| FGF 21, pg/mL | 203.0±142.2 | 196.8±125.3 | 201.8±162.9 | 210.4±136.7 | 0.76 |
| Leptin, ng/mL | 14.3±12.0 | 13.7±12.2 | 15.0±12.3 | 14.3±11.5 | 0.44 |
*Values are presented as mean±SD for continuous variables (unless indicated otherwise), and as number and/or % for categorical variables.
†P values according to ANOVA/Kruskal-Wallis test for continuous variables and χ2 for categorical variables.
‡Of 269 available H-MRS.
§BMI ≥30 kg/m2.
¶Presence of diabetes was defined for participants with baseline fasting plasma glucose levels ≥126 mg/dL or haemoglobin-A1c levels ≥6.5% or if regularly treated with oral antihyperglycaemic medications or exogenous insulin.
**Values presented as median (p25, p75).
ALKP, alkaline phosphatase; ALT, alanine transaminase; ANOVA, analysis of variance; AST, aspartate transaminase; BMI, body mass index; BP, blood pressure; FGF, fibroblast growth factor; HDG, heathy dietary guidelines; HDL, high-density lipoprotein; H-MRS, proton magnetic resonance spectroscopy; hsCRP, high sensitivity C reactive protein; IHF, intrahepatic fat; HOMA IR, homeostatic model assessment of insulin resistance; LDL, Low-density lipoprotein ; MED, Mediterranean; NAFLD, non-alcoholic fatty liver disease; TG, triglycerides.