TABLE 1.
Participant baseline characteristics
| Total | Ketogenic diet app with biofeedback | Calorie‐restricted, low‐fat diet app | |
|---|---|---|---|
| N | 155 | 77 | 78 |
| Age, mean (SD), y | 41 (11) | 42 (11) | 41 (11) |
| Female, n (%) | 110 (71) | 55 (71) | 55 (71) |
| Male, n (%) | 45 (29) | 22 (29) | 23 (29) |
| Weight, mean (SD), kg | 94.4 (16.0) | 94.7 (17.1) | 94.1 (14.7) |
| BMI, mean (SD) | 33.5 (4.7) | 33.5 (4.7) | 33.6 (4.7) |
| Secondary outcomes a | |||
| HbA1c (%) | 5.4 (0.5) | 5.4 (0.6) | 5.4 (0.5) |
| HbA1c (mmol/mol) | 35.6 (5.9) | 36.0 (6.2) | 34.2 (6.0) |
| Glucose (mmol/L) | 5.4 (1.1) | 5.4 (1.4) | 5.3 (0.8) |
| Insulin (pmol/L) | 76 (61) | 76 (52) | 76 (68) |
| HOMA‐IR (a.u.) b | 3.2 (3.2) | 3.1 (2.5) | 3.2 (3.7) |
| hs‐CRP (mg/L) | 4.4 (4.2) | 4.6 (4.2) | 4.2 (4.1) |
| Total cholesterol (mmol/L) | 5.2 (1.0) | 5.1 (1.0) | 5.3 (1.1) |
| HDL cholesterol (mmol/L) | 1.4 (0.3) | 1.4 (0.3) | 1.4 (0.4) |
| Cholesterol/HDL ratio | 4.0 (1.1) | 4.0 (1.1) | 3.9 (1.1) |
| LDL cholesterol (mmol/L) c | 3.2 (0.8) | 3.1 (0.8) | 3.2 (0.9) |
| Non‐HDL cholesterol (mmol/L) d | 3.8 (1.0) | 3.8 (1.0) | 3.9 (1.0) |
| Triglycerides (mmol/L) | 1.7 (1.1) | 1.7 (1.0) | 1.6 (1.2) |
| LDL particle number (nmol/L) | 1,396 (335) | 1,378 (343) | 1,413 (327) |
| Small LDL particles (nmol/L) | 258 (138) | 258 (132) | 258 (125) |
| Medium LDL particles (nmol/L) | 290 (102) | 283 (103) | 298 (101) |
| LDL particle size (nm) | 21.7 (0.7) | 21.7 (0.7) | 21.8 (0.6) |
| Large HDL particles (nmol/L) | 5,597 (1,308) | 5,460 (1,120) | 5,734 (1,467) |
| Apolipoprotein B (g/L) | 1.0 (0.2) | 1.0 (0.2) | 1.0 (0.2) |
| Lipoprotein (a) (nmol/L) | 53 (73) | 56 (79) | 51 (67) |
| Exploratory outcomes a | |||
| Albumin (g/L) | 44 (3) | 43 (3) | 44 (3) |
| Globulin (g/L) | 27 (3) | 26 (3) | 28 (3) |
| Total bilirubin (µmol/L) | 10.3 (6.8) | 10.3 (3.4) | 12.0 (8.6) |
| ALP (U/L) | 67 (19) | 67 (19) | 66 (18) |
| AST (U/L) | 22 (19) | 22 (23) | 22 (15) |
| ALT (U/L) | 25 (19) | 25 (18) | 26 (20) |
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; HbA1c, hemoglobin A1c; HDL cholesterol, high‐density lipoprotein cholesterol; HOMA‐IR, homeostasis model assessment of insulin resistance; hs‐CRP, high‐sensitivity C‐reactive protein; LDL cholesterol, low‐density lipoprotein cholesterol.
a
All markers assessed in a fasted state. Data presented as mean (SD).
b
Calculated as: fasting insulin (μIU/mL) * fasting glucose (mmol/L) / 22.5.
c
Calculated with Martin‐Hopkins Formula (28).
d
Calculated as: total cholesterol – HDL cholesterol.