Table 2.
Primary and secondary outcomes at 3 months, 6 months, and 1 year after enrollment.
| Outcomes | n | Mean Change from Baseline | Between-Group Differences | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Unadjusted | Adjusted a | ||||||||
| Healthy Ketogenic Diet (n = 41) |
Energy- Restricted Diet (n = 39) |
Mean Difference (95% CI) | p-Value | Cohen d | Mean Difference (95% CI) | p-Value | Cohen d | ||
| ∆ Weight, kg | |||||||||
| 3 months | 72 | −5.8 ± 3.9 * | −2.8 ± 3.3 * | −3.0 (−4.7–−1.3) | 0.001 | 0.83 | −3.0 (−4.6–−1.4) | <0.001 | 0.44 |
| 6 months | 59 | −7.8 ± 5.2 * | −4.2 ± 5.6 * | −3.7 (−6.5–−0.9) | 0.012 | 0.67 | −3.6 (−6.4–−0.9) | 0.010 | 0.35 |
| 12 months | 51 | −6.9 ± 6.4 * | −4.6 ± 5.8 * | −2.2 (−5.6–1.2) | 0.202 | 0.38 | −1.5 (−4.8–1.7) | 0.353 | 0.13 |
| ∆ Weight, % | |||||||||
| 3 months | 72 | −6.8 ± 4.2 | −3.3 ± 3.6 | −3.5 (−5.4–−1.7) | <0.001 | 0.89 | −3.7 (−5.6–−1.9) b | <0.001 b | 0.49 b |
| 6 months | 59 | −9.3 ± 5.9 | −4.9 ± 5.8 | −4.4 (−7.5–−1.4) | 0.005 | 0.75 | −4.6 (−7.6–−1.5) b | 0.004 b | 0.39 b |
| 12 months | 51 | −7.9 ± 7.7 | −5.4 ± 6.2 | −2.6 (−6.5–1.4) | 0.199 | 0.36 | −2.7 (−6.6–1.3) b | 0.177 b | 0.19 b |
| ∆ BMI, kg/m2 | |||||||||
| 3 months | 72 | −2.2 ± 1.4 * | −1.0 ± 1.2 * | −1.2 (−1.8–−0.6) | <0.001 | 0.92 | −1.2 (−1.8–−0.6) | <0.001 | 0.48 |
| 6 months | 59 | −3.0 ± 2.0 * | −1.5 ± 1.9 * | −1.5 (−2.5–−0.5) | 0.004 | 0.77 | −1.6 (−2.6–−0.5) | 0.003 | 0.40 |
| 12 months | 51 | −2.6 ± 2.5 * | −1.7 ± 2.0 * | −0.9 (−2.2–0.3) | 0.142 | 0.40 | −1.0 (−2.2–0.3) | 0.128 | 0.22 |
| ∆ ALT, U/L | |||||||||
| 3 months | 71 | −14.4 ± 27.8 * | −4.9 ± 15.9 | −9.5 (−20.3–1.4) | 0.086 | 0.42 | −3.6 (−8.0–0.9) | 0.113 | 0.19 |
| 6 months | 59 | −19.0 ± 32.5 * | −5.7 ± 23.4 | −13.3 (−28.0–1.4) | 0.076 | 0.47 | −4.0 (−8.0–0.0) | 0.051 | 0.26 |
| 12 months | 51 | −19.2 ± 38.2 * | −0.9 ± 23.8 | −18.3 (−36.4–−0.1) | 0.049 | 0.58 | −11.1 (−21.9–−0.2) | 0.045 | 0.29 |
| ∆ AST, U/L | |||||||||
| 3 months | 71 | −6.7 ± 14.5 * | −1.4 ± 8.7 | −5.3 (−11.0–0.5) | 0.071 | 0.44 | −2.3 (−5.1–0.6) | 0.124 | 0.19 |
| 6 months | 59 | −7.6 ± 15.5 * | 0.6 ± 11.5 | −8.2 (−15.3–−1.1) | 0.024 | 0.60 | −4.1 (−7.1–−1.0) | 0.010 | 0.35 |
| 12 months | 51 | −8.3 ± 18.2 * | 1.8 ± 11.7 | −10.1 (−18.9–−1.4) | 0.024 | 0.66 | −5.5 (−10.4–−0.6) | 0.028 | 0.32 |
| ∆ HbA1c, % | |||||||||
| 3 months | 71 | −0.3 ± 0.3 * | −0.1 ± 0.2 * | −0.2 (−0.3–−0.1) | 0.005 | 0.78 | −0.1 (−0.2–0.00) | 0.060 | 0.24 |
| 6 months | 59 | −0.3 ± 0.3 * | −0.1 ± 0.2 | −0.2 (−0.3–−0.1) | 0.002 | 0.78 | −0.2 (−0.3–−0.0) | 0.008 | 0.37 |
| 12 months | 51 | −0.3 ± 0.3 * | −0.1 ± 0.2 * | −0.2 (−0.3–0.0) | 0.037 | 0.78 | −0.1 (−0.2–0.0) | 0.145 | 0.21 |
| ∆ Fasting Blood Glucose, mmol/L | |||||||||
| 3 months | 71 | −0.4 ± 0.5 * | −0.2 ± 0.6 * | −0.1 (−0.4–0.1) | 0.277 | 0.36 | 0.0 (−0.2–0.2) | 0.972 | 0.00 |
| 6 months | 59 | −0.4 ± 0.5 * | −0.2 ± 0.5 * | −0.2 (−0.4–0.1) | 0.172 | 0.40 | −0.1 (−0.4–0.2) | 0.415 | 0.10 |
| 12 months | 51 | −0.3 ± 0.5 * | −0.2 ± 0.5 * | −0.1 (−0.4–0.2) | 0.421 | 0.20 | −0.0 (−0.3–0.3) | 0.924 | 0.01 |
| ∆ Systolic blood pressure, mmHg | |||||||||
| 3 months | 71 | −7.1 ± 7.4 * | −4.1 ± 14.5 | −3.0 (−8.3–2.4) | 0.275 | 0.26 | −3.5 (−7.9–0.9) | 0.121 | 0.19 |
| 6 months | 59 | −7.7 ± 8.9 * | −2.6 ± 12.2 | −5.1 (−10.7–0.5) | 0.071 | 0.48 | −6.4 (−10.7–−2.0) | 0.005 | 0.38 |
| 12 months | 51 | −4.2 ± 10.7 | −5.7 ± 9.5 * | 1.5 (−4.2–7.2) | 0.605 | 0.15 | 0.4 (−4.7–5.5) | 0.887 | 0.02 |
| ∆ Diastolic blood pressure, mmHg | |||||||||
| 3 months | 71 | −3.1 ± 7.0 * | −5.0 ± 9.9 * | 1.9 (−2.2–5.9) | 0.359 | 0.22 | 1.5 (−2.2–5.2) | 0.424 | 0.10 |
| 6 months | 59 | −3.7 ± 6.5 * | −2.4 ± 7.7 | −1.4 (−5.1–2.4) | 0.468 | 0.18 | −1.6 (−5.0–1.9) | 0.359 | 0.12 |
| 12 months | 51 | −2.1 ± 8.8 | −2.6 ± 9.2 | 0.5 (−4.6–5.6) | 0.841 | 0.06 | 0.3 (−4.6–5.1) | 0.917 | 0.01 |
| ∆ Total cholesterol, mmol/L | |||||||||
| 3 months | 71 | −0.42 ± 0.75 * | −0.16 ± 0.55 | −0.26 (−0.57–0.05) | 0.098 | 0.40 | −0.13 (−0.39–0.13) | 0.331 | 0.12 |
| 6 months | 59 | −0.29 ± 0.75 * | −0.08 ± 0.67 | −0.21 (−0.58–0.17) | 0.273 | 0.30 | −0.10 (−0.43–0.23) | 0.551 | 0.08 |
| 12 months | 51 | −0.44 ± 0.71 * | 0.06 ± 0.87 | −0.50 (−0.95–−0.06) | 0.027 | 0.63 | −0.47 (−0.91–−0.03) | 0.036 | 0.30 |
| ∆ HDL-cholesterol, mmol/L | |||||||||
| 3 months | 71 | −0.04 ± 0.24 | −0.01 ± 0.17 | −0.02 (−0.12–0.07) | 0.626 | 0.14 | −0.01 (−0.11–0.08) | 0.760 | 0.03 |
| 6 months | 59 | 0.05 ± 0.19 | 0.01 ± 0.20 | 0.04 (−0.06–0.15) | 0.404 | 0.21 | 0.04 (−0.06–0.14) | 0.406 | 0.11 |
| 12 months | 51 | 0.09 ± 0.19 * | 0.01 ± 0.21 | 0.08 (−0.03–0.19) | 0.161 | 0.40 | 0.08 (−0.03–0.18) | 0.161 | 0.21 |
| ∆ Triglycerides, mmol/L | |||||||||
| 3 months | 71 | −0.44 ± 0.68 * | −0.06 ± 0.39 | −0.38 (−0.65–−0.12) | 0.005 | 0.69 | −0.20 (−0.34–−0.06) | 0.006 | 0.33 |
| 6 months | 59 | −0.49 ± 0.80 * | −0.13 ± 0.57 | −0.36 (−0.72–0.00) | 0.051 | 0.52 | −0.17 (−0.42–0.08) | 0.181 | 0.18 |
| 12 months | 51 | −0.57 ± 0.88 * | −0.04 ± 0.66 | −0.53 (−0.98–−0.09) | 0.020 | 0.68 | −0.40 (−0.78–−0.03) | 0.036 | 0.30 |
| ∆ LDL-cholesterol, mmol/L | |||||||||
| 3 months | 71 | −0.19 ± 0.69 | −0.11 ± 0.39 | −0.08 (−0.35–0.19) | 0.554 | 0.14 | −0.01 (−0.24–0.22) | 0.924 | 0.01 |
| 6 months | 59 | −0.12 ± 0.60 | −0.04 ± 0.56 | −0.08 (−0.38–0.23) | 0.620 | 0.14 | 0.00 (−0.27–0.26) | 0.970 | 0.00 |
| 12 months | 51 | −0.27 ± 0.58 * | 0.07 ± 0.76 | −0.35 (−0.72–0.03) | 0.070 | 0.50 | −0.33 (−0.69–0.03) | 0.073 | 0.26 |
Data expressed as mean ± SD. BMI, Body Mass Index; ALT, Alanine Transaminase; AST, Aspartate Transaminase, HbA1c, Glycated Hemoglobin; HDL, High-density Lipoprotein; LDL, Low-density Lipoprotein. a Adjusted for gender, age, and baseline value of the outcome. b Adjusted for gender and age. * Significant within-group changes p-values after Benjamini–Hochberg correction with false discovery rate at 0.20 and n = 72. In bold: Significant between-group differences p-Values after Benjamini–Hochberg correction with false discovery rate at 0.20 and n = 78.