The Effect of Short-Term Healthy Ketogenic Diet Ready-To-Eat Meals Versus Healthy Ketogenic Diet Counselling on Weight Loss in Overweight Adults: A Pilot Randomized Controlled Trial
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Participants
2.3. Run-In Period
2.4. Randomization and Masking
2.5. Intervention
2.6. Outcome Evaluation
2.7. Anthropometric and Biochemical Measurements
2.8. Sample Size
2.9. Statistical Analysis
3. Results
3.1. Study Participants
3.2. Baseline Characteristics
3.3. Adherence to Diet Prescription
3.4. Changes in the Body Weight and Metabolic Parameters
3.5. Cardiometabolic Outcomes
3.6. Dietary Intake
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | HKD-RTE (n = 24) | HKD (n = 26) | p Value a |
---|---|---|---|
Gender, n (%) | |||
Female | 20 (83.3%) | 22 (84.6%) | 1.000 |
Male | 4 (16.7%) | 4 (15.4%) | |
Ethnicity, n (%) | |||
Chinese | 13 (54.2%) | 18 (69.2%) | 0.633 |
Malay | 2 (8.3%) | 1 (3.8%) | |
Indian | 5 (20.8%) | 3 (11.5%) | |
Others | 4 (16.7%) | 4 (15.4%) | |
Age (years) | |||
Mean | 43.3 ± 7.3 | 39.0 ± 10.7 | 0.111 |
Range | 26–54 | 24–69 | |
Weight, kg/m2 | 81.7 ± 15.8 | 83.4 ± 13.2 | 0.685 |
Body Mass Index, kg/m2 | 31.6 ± 4.6 | 32.2 ± 4.4 | 0.691 |
Systolic blood pressure, mmHg | 126.6 ± 12.9 | 122.4 ± 14.3 | 0.272 |
Diastolic blood pressure, mmHg | 83.1 ± 8.3 | 77.7 ± 9.9 | 0.042 |
HbA1c, % | 6.0 ± 1.1 | 5.7 ± 0.6 | 0.391 |
Fasting blood glucose, mmol/L | 5.7 ± 1.6 | 5.4 ± 0.9 | 0.413 |
Total cholesterol, mmol/L | 5.2 ± 1.1 | 5.0 ± 0.7 | 0.487 |
Triglyceride, mmol/L | 1.4 ± 0.8 | 1.2 ± 0.4 | 0.425 |
LDL cholesterol, mmol/L | 3.3 ± 1.0 | 3.3 ± 0.7 | 0.918 |
HDL cholesterol, mmol/L | 1.3 ± 0.2 | 1.2 ± 0.2 | 0.310 |
Co-morbidity, n (%) | |||
Hypertension | |||
No | 8 (33.3%) | 14 (53.8%) | 0.144 |
Yes | 16 (66.7%) | 12 (46.2%) | |
Diabetes | |||
No | 18 (75.0%) | 21 (80.8%) | 0.623 |
Yes | 6 (25.0%) | 5 (19.2%) | |
Hyperlipidemia | |||
No | 4 (16.7%) | 4 (15.4%) | 1.000 |
Yes | 20 (83.3%) | 22 (84.6%) | |
Nutrient intake | |||
Calorie, kcal | 1229 ± 372 | 1422 ± 464 | 0.114 |
Protein, g | 64.1 ± 20.8 | 69.8 ± 27.1 | 0.416 |
Total fat, g | 52.5 ± 18.0 | 60.6 ± 26.5 | 0.219 |
Saturated fat, g | 19.9 ± 8.9 | 23.2 ± 12.0 | 0.275 |
MUFA, g | 18.9 ± 5.9 | 21.9 ± 11.4 | 0.237 |
PUFA, g | 9.3 ± 3.5 | 10.3 ± 4.2 | 0.392 |
Trans fat, g | 0.2 ± 0.2 | 0.2 ± 0.3 | 0.379 |
Carbohydrate, g | 126.0 ± 54.3 | 150.1 ± 38.7 | 0.075 |
Net Carbohydrate, g | 114.8 ± 53.1 | 138.2 ± 37.4 | 0.077 |
Sugar, g | 31.4 ± 21.1 | 35.2 ± 14.4 | 0.452 |
Fiber, g | 11.1 ± 4.5 | 11.9 ± 3.7 | 0.463 |
Sodium, mg | 2358 ± 962 | 2514 ± 1193 | 0.614 |
Step count | 7796.3 ± 3544.5 | 6409.4 ± 3915.7 | 0.204 |
Unadjusted | Adjusted | ||||||||
---|---|---|---|---|---|---|---|---|---|
Outcomes | n | Mean Change from Baseline | Between-Group Differences | Between-Group Differences a | |||||
HKD-RTE (n = 24) | HKD (n = 26) | Mean Difference (95% CI) | p Value | Cohen d | Mean Difference (95% CI) | p Value | Cohen d | ||
∆ Weight, kg | |||||||||
1 month | 48 | −3.9 ± 2.6 * | −1.7 ± 4.3 | −2.2 (−4.3–−0.1) | 0.040 | 0.63 | −1.8 (−3.8–0.2) | 0.078 | 0.26 |
3 month | 48 | −6.1 ± 3.9 * | −4.4 ± 3.1 * | −1.7 (−3.8–0.3) | 0.096 | 0.49 | −1.5 (−4.0–1.0) | 0.245 | 0.18 |
6 month | 45 | −7.0 ± 5.8 * | −3.3 ± 6.2 * | −3.7 (−7.3–−0.1) | 0.046 | 0.62 | −4.7 (−10.3–0.9) | 0.096 | 0.26 |
∆ Weight, % | |||||||||
1 month | 48 | −4.8 ± 3.0 | −1.8 ± 6.2 | −3.0 (−6.0–−0.2) | 0.040 | 0.63 | −2.4 (−5.4–0.5) b | 0.106 b | 0.24 b |
3 month | 48 | −7.6 ± 4.6 | −5.3 ± 3.6 | −2.3 (−4.7–0.1) | 0.057 | 0.56 | −1.7 (−4.5–1.1) b | 0.223 b | 0.18 b |
6 month | 45 | −8.6 ± 6.8 | −3.9 ± 8.6 | −4.7 (−9.4–−0.0) | 0.049 | 0.61 | −6.2 (−13.4–1.1) b | 0.092 b | 0.27 b |
∆ BMI, kg/m2 | |||||||||
1 month | 48 | −1.5 ± 1.0 * | −0.7 ± 1.6 * | −0.9 (−1.6–−0.1) | 0.032 | 0.65 | −0.7 (−1.5–0.1) | 0.078 | 0.27 |
3 month | 48 | −2.4 ± 1.5 * | −1.4 ± 1.9 * | −1.0 (−2.0–0.0) | 0.051 | 0.58 | −0.8 (−1.9–0.4) | 0.185 | 0.20 |
6 month | 45 | −2.7 ± 2.1 * | −1.3 ± 2.3 * | −1.4 (−2.8–−0.1) | 0.037 | 0.65 | −1.9 (−4.0–0.2) | 0.075 | 0.28 |
∆ Systolic blood pressure | |||||||||
3 month | 48 | −10.2 ± 12.7 * | −6.7 ± 10.5 * | −3.5 (−10.3–3.2) | 0.298 | 0.30 | −1.0 (−7.7–5.7) | 0.756 | 0.04 |
6 month | 45 | −8.3 ± 9.7 * | −5.3 ± 11.0 * | −3.0 (−9.3–3.2) | 0.335 | 0.29 | −6.1 (−15.2–3.0) | 0.178 | 0.21 |
∆ Diastolic blood pressure | |||||||||
3 month | 48 | −8.3 ± 6.8 * | −5.3 ± 8.2 * | −3.0 (−7.5–1.4) | 0.173 | 0.40 | −1.7 (−6.3–2.8) | 0.437 | 0.11 |
6 month | 45 | −7.7 ± 8.8 * | −2.0 ± 7.0 | −5.8 (−10.5–−1.0) | 0.019 | 0.72 | −6.4 (−13.2–0.5) | 0.066 | 0.29 |
∆ HbA1c, % | |||||||||
3 month | 48 | −0.4 ± 0.6 * | −0.3 ± 0.3 * | −0.1 (−0.4–0.1) | 0.281 | 0.30 | −0.1 (−0.2–0.0) | 0.198 | 0.22 |
6 month | 45 | −0.3 ± 0.5 * | −0.1 ± 0.4 | −0.1 (−0.4–0.2) | 0.425 | 0.23 | 0.0 (−0.2–0.2) | 0.764 | 0.00 |
∆ Fasting Blood Glucose, mmol/L | |||||||||
3 month | 48 | −0.4 ± 0.7 * | −0.2 ± 0.5 | −0.2 (−0.5–0.2) | 0.347 | 0.27 | −0.1 (−0.4–0.2) | 0.389 | 0.11 |
6 month | 45 | −0.3 ± 0.7 | −0.3 ± 0.7 * | −0.0 (−0.4–0.4) | 0.970 | 0.01 | 0.2 (−0.2–0.6) | 0.246 | 0.16 |
∆ Total cholesterol, mmol/L | |||||||||
3 month | 48 | −0.45 ± 0.59 * | −0.21 ± 0.65 | −0.23 (−0.60–0.13) | 0.202 | 0.39 | −0.32 (−0.75–0.10) | 0.131 | 0.22 |
6 month | 45 | −0.54 ± 0.76 * | −0.05 ± 0.56 | −0.48 (−0.88–−0.09) | 0.019 | 0.73 | −0.32 (−0.92–0.28) | 0.283 | 0.17 |
∆ HDL cholesterol, mmol/L | |||||||||
3 month | 71 | −0.06 ± 0.15 | −0.08 ± 0.13 * | 0.03 (−0.06–0.11) | 0.533 | 0.14 | 0.03 (−0.06–0.11) | 0.522 | 0.08 |
6 month | 59 | 0.02 ± 0.16 | 0.03 ± 0.13 | −0.01 (−0.09–0.08) | 0.892 | 0.07 | 0.02 (−0.12–0.15) | 0.814 | 0.04 |
∆ Triglycerides, mmol/L | |||||||||
3 month | 48 | −0.19 ± 0.44 | −0.23 ± 0.37 * | 0.04 (−0.20–0.28) | 0.730 | 0.10 | 0.07 (−0.18–0.33) | 0.566 | 0.08 |
6 month | 45 | −0.26 ± 0.44 * | −0.13 ± 0.35 | −0.12 (−0.36–0.11) | 0.300 | 0.33 | −0.25 (−0.56–0.07) | 0.122 | 0.25 |
∆ LDL cholesterol, mmol/L | |||||||||
3 month | 48 | −0.29 ± 0.49 * | −0.03 ± 0.61 | −0.26 (−0.59–0.06) | 0.110 | 0.47 | −0.35 (−0.73–0.03) | 0.066 | 0.27 |
6 month | 45 | −0.43 ± 0.67 * | −0.03 ± 0.52 | −0.41 (−0.77–−0.05) | 0.027 | 0.67 | −0.23 (−0.75–0.30) | 0.374 | 0.14 |
∆ Energy, kcal | |||||||||
1 month | 46 | −282 ± 285 * | −679 ± 409 * | 383 (176–590) | <0.001 | 1.13 | 280 (140–420) | <0.001 | 0.60 |
3 month | 44 | −441 ± 240 * | −604 ± 507 * | 164 (−82–409) | 0.185 | 0.41 | 33 (−147–213) | 0.716 | 0.06 |
6 month | 22 | −460 ± 329 * | −593 ± 465 * | 133 (−244–509) | 0.471 | 0.33 | 20 (−318–358) | 0.900 | 0.03 |
∆ Protein, g | |||||||||
1 month | 46 | 1.8 ± 15.1 | −20.0 ± 24.5 * | 20.0 (8.0–32.1) | 0.002 | 1.07 | 18.9 (9.0–28.8) | <0.001 | 0.57 |
3 month | 44 | −12.3 ± 18.4 * | −14.3 ± 41.4 | 2.0 (−17.8–21.8) | 0.842 | 0.06 | −2.2 (−19.9–15.5) | 0.802 | 0.04 |
6 month | 22 | −22.9 ± 19.3 * | −22.4 ± 28.9 * | −0.5 (−23.6–22.6) | 0.964 | 0.02 | 2.5 (−17.2 to 22.1) | 0.791 | 0.06 |
∆ Total fat, g | |||||||||
1 month | 46 | −6.8 ± 16.3 | −24.1 ± 23.0 * | 16.5 (4.6–28.3) | 0.007 | 0.86 | 13.1 (5.2–21.1) | 0.002 | 0.49 |
3 month | 44 | −15.0 ± 12.9 * | −20.8 ± 30.6 * | 5.8 (−8.7–20.3) | 0.425 | 0.25 | −0.2 (−11.3–11.0) | 0.978 | 0.01 |
6 month | 22 | −11.8 ± 13.4 * | −21.2 ± 28.3 * | 9.5 (−11.8–30.7) | 0.365 | 0.43 | 5.8 (−10.0–21.5) | 0.443 | 0.17 |
∆ Saturated fat, g | |||||||||
1 month | 46 | −6.2 ± 8.8 * | −10.6 ± 11.1 * | 4.2 (−1.8–10.1) | 0.166 | 0.44 | 2.0 (−1.2–5.2) | 0.217 | 0.19 |
3 month | 44 | −7.8 ± 7.7 * | −9.3 ± 13.2 * | 1.5 (−5.1–8.2) | 0.646 | 0.14 | −0.3 (−4.8–4.1) | 0.878 | 0.02 |
6 month | 22 | −6.7 ± 5.0 * | −8.8 ± 11.3 * | 2.1 (−6.4–10.5) | 0.615 | 0.24 | 1.2 (−5.3–7.7) | 0.691 | 0.09 |
∆ MUFA, g | |||||||||
1 month | 46 | −0.7 ± 5.8 | −8.0 ± 9.0 * | 7.1 (2.6–11.6) | 0.003 | 0.97 | 5.0 (2.1–8.0) | 0.001 | 0.51 |
3 month | 44 | −4.9 ± 6.4 * | −8.6 ± 12.8 * | 3.6 (−2.6–9.9) | 0.246 | 0.36 | 1.0 (−3.5–5.4) | 0.660 | 0.07 |
6 month | 22 | −1.7 ± 6.9 | −8.6 ± 13.7 * | 6.9 (−3.5–17.3) | 0.184 | 0.63 | 2.2 (−5.2–9.7) | 0.529 | 0.14 |
∆ PUFA, g | |||||||||
1 month | 46 | 0.4 ± 4.0 | −3.0 ± 4.8 * | 3.1 (0.5–5.7) | 0.019 | 0.75 | 2.8 (0.4–5.2) | 0.022 | 0.35 |
3 month | 44 | −1.8 ± 5.0 | −3.3 ± 4.9 * | 1.6 (−1.5–4.6) | 0.307 | 0.32 | 1.8 (−1.1–4.7) | 0.208 | 0.19 |
6 month | 22 | −1.0 ± 4.7 | −2.5 ± 5.3 | 1.5 (−3.1–6.1) | 0.493 | 0.31 | 1.3 (−1.4–4.0) | 0.312 | 0.23 |
∆ Dietary Cholesterol, mg | |||||||||
1 month | 46 | −7.73 ± 185.69 | −85.58 ± 200.99 | 69.59 (−45.79–184.96) | 0.231 | 0.40 | 66.66 (−21.27–154.59) | 0.133 | 0.23 |
3 month | 44 | −119.63 ± 190.38 * | −30.85 ± 269.06 | −88.79 (−231.86–54.29) | 0.217 | 0.38 | −99.49 (−210.70–11.73) | 0.078 | 0.27 |
6 month | 22 | −111.94 ± 218.84 | −74.81 ± 185.63 | −37.14 (−217.66–143.39) | 0.672 | 0.18 | 31.01 (−87.47–149.50) | 0.579 | 0.12 |
∆ Trans fat, g | |||||||||
1 month | 46 | −0.1 ± 0.1 * | −0.2 ± 0.3 * | 0.1 (−0.0–0.2) | 0.088 | 0.53 | 0.1 (0.0–0.1) | 0.038 | 0.51 |
3 month | 44 | −0.1 ± 0.3 | −0.1 ± 0.4 | 0.1 (−0.1–0.3) | 0.358 | 0.27 | 0.0 (−0.1–0.2) | 0.735 | 0.00 |
6 month | 22 | −0.1 ± 0.3 | −0.1 ± 0.2 * | 0.0 (−0.2–0.2) | 0.836 | 0.09 | 0.1 (0.0–0.1) | 0.045 | 0.76 |
∆ Carbohydrate, g | |||||||||
1 month | 46 | −56.6 ± 53.4 * | −95.5 ± 41.4 * | 38.8 (10.6–67.1) | 0.008 | 0.81 | 18.4 (2.4–34.3) | 0.025 | 0.34 |
3 month | 44 | −66.6 ± 45.3 * | −92.4 ± 33.6 * | 25.8 (1.7–49.9) | 0.036 | 0.65 | 10.0 (−2.2–22.2) | 0.106 | 0.25 |
6 month | 22 | −63.6 ± 60.0 * | −77.0 ± 45.2 * | 13.5 (−33.3–60.2) | 0.555 | 0.25 | −9.0 (−48.1–30.0) | 0.623 | 0.11 |
∆ Net Carbohydrate, g | |||||||||
1 month | 46 | −61.6 ± 54.1 * | −93.5 ± 40.4 * | 32.2 (3.9–60.5) | 0.027 | 0.67 | 11.1 (−4.2–26.4) | 0.152 | 0.22 |
3 month | 44 | −66.8 ± 47.0 * | −90.4 ± 30.1 * | 23.7 (−0.1–47.5) | 0.051 | 0.60 | 8.9 (−3.0–20.9) | 0.138 | 0.23 |
6 month | 22 | −62.5 ± 60.7 * | −75.1 ± 41.3 * | 12.6 (−32.6–57.8) | 0.568 | 0.24 | −6.4 (−43.0–30.2) | 0.710 | 0.08 |
∆ Sugar, g | |||||||||
1 month | 46 | −14.5 ± 19.6 * | −24.4 ± 16.6 * | 9.8 (−1.0–20.4) | 0.073 | 0.54 | 6.9 (1.9–12.0) | 0.009 | 0.41 |
3 month | 44 | −17.7 ± 20.6 * | −23.1 ± 15.5 * | 5.4 (−5.6–16.4) | 0.328 | 0.30 | 1.8 (−3.5–7.1) | 0.489 | 0.10 |
6 month | 22 | −17.9 ± 19.2 * | −17.1 ± 20.2 * | −0.8 (−18.7–17.1) | 0.925 | 0.04 | −0.7 (−12.9–11.6) | 0.909 | 0.03 |
∆ Fiber, g | |||||||||
1 month | 46 | 5.0 ± 6.2 * | −2.0 ± 5.3 | 6.8 (3.5–10.1) | <0.001 | 1.22 | 6.7 (3.1–10.4) | <0.001 | 0.55 |
3 month | 44 | 0.5 ± 6.9 | −1.9 ± 6.6 | 2.4 (−1.8–6.5) | 0.253 | 0.35 | 0.7 (−3.6–4.9) | 0.757 | 0.05 |
6 month | 22 | −0.7 ± 2.6 | −2.0 ± 8.9 | 1.3 (−5.1–7.7) | 0.669 | 0.20 | −1.8 (−10.0–6.4) | 0.647 | 0.10 |
∆ Sodium, mg | |||||||||
1 month | 46 | −83 ± 779 | −789 ± 963 * | 652 (143–1162) | 0.013 | 0.81 | 671 (216–1126) | 0.005 | 0.44 |
3 month | 44 | −471 ± 764 * | −707 ± 1419 * | 237 (−467–940) | 0.501 | 0.21 | 231 (−333–794) | 0.410 | 0.13 |
6 month | 22 | −740 ± 780 * | −990 ± 1074 | 250 (−625–1125) | 0.558 | 0.27 | 121 (−481–724) | 0.668 | 0.09 |
Weight Loss < 5% | Weight Loss ≥ 5% | OR (95% CI) a | p Value | |
---|---|---|---|---|
1 month | ||||
HKD-RTE | 13 (59.1%) | 9 (40.9%) | 4.3 (0.9–20.2) | 0.069 |
HKD | 21 (80.8%) | 5 (19.2%) | 1.0 | |
3 month | ||||
HKD-RTE | 8 (36.4%) | 14 (63.6%) | 1.02 (0.24–4.41) | 0.975 |
HKD | 11 (42.3%) | 15 (57.7%) | 1.0 | |
6 month | ||||
HKD-RTE | 8 (38.1%) | 13 (61.9%) | 1.4 (0.2–8.4) | 0.714 |
HKD | 11 (45.8%) | 13 (54.2%) | 1.0 |
Unadjusted | Adjusted | |||
---|---|---|---|---|
Mean Difference (95% CI) | p-Value | Mean Difference (95% CI) | p-Value | |
1 month ∆ Weight, kg | ||||
Percentage compliance | −0.05 (−0.10–0.01) | 0.091 | −0.05 (−0.12–0.02) a | 0.153 a |
3 month ∆ Weight, kg | ||||
Percentage compliance | −0.083 (−0.163–0.002) | 0.044 | −0.109 (−0.218–0.001) a | 0.049 a |
6 month ∆ Weight, kg | ||||
Percentage compliance | −0.14 (−0.25–−0.02) | 0.021 | −0.22 (−0.52–0.07) a | 0.110 a |
1 month ∆ Weight, % | ||||
Percentage compliance | −0.06 (−0.12–0.00) | 0.065 | −0.04 (−0.12–0.04) b | 0.285 b |
3 month ∆ Weight, % | ||||
Percentage compliance | −0.11 (−0.20–−0.01) | 0.030 | −0.10 (−0.23–0.02) b | 0.089 b |
6 month ∆ Weight, % | ||||
Percentage compliance | −0.17 (−0.30–−0.04) | 0.016 | −0.22 (−0.49–0.05) b | 0.091 b |
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Tay, M.H.J.; Yap, Q.V.; Lim, S.L.; Ong, Y.W.Y.; Wee, V.C.H.T.; Khoo, C.M. The Effect of Short-Term Healthy Ketogenic Diet Ready-To-Eat Meals Versus Healthy Ketogenic Diet Counselling on Weight Loss in Overweight Adults: A Pilot Randomized Controlled Trial. Nutrients 2025, 17, 2541. https://doi.org/10.3390/nu17152541
Tay MHJ, Yap QV, Lim SL, Ong YWY, Wee VCHT, Khoo CM. The Effect of Short-Term Healthy Ketogenic Diet Ready-To-Eat Meals Versus Healthy Ketogenic Diet Counselling on Weight Loss in Overweight Adults: A Pilot Randomized Controlled Trial. Nutrients. 2025; 17(15):2541. https://doi.org/10.3390/nu17152541
Chicago/Turabian StyleTay, Melissa Hui Juan, Qai Ven Yap, Su Lin Lim, Yuki Wei Yi Ong, Victoria Chantel Hui Ting Wee, and Chin Meng Khoo. 2025. "The Effect of Short-Term Healthy Ketogenic Diet Ready-To-Eat Meals Versus Healthy Ketogenic Diet Counselling on Weight Loss in Overweight Adults: A Pilot Randomized Controlled Trial" Nutrients 17, no. 15: 2541. https://doi.org/10.3390/nu17152541
APA StyleTay, M. H. J., Yap, Q. V., Lim, S. L., Ong, Y. W. Y., Wee, V. C. H. T., & Khoo, C. M. (2025). The Effect of Short-Term Healthy Ketogenic Diet Ready-To-Eat Meals Versus Healthy Ketogenic Diet Counselling on Weight Loss in Overweight Adults: A Pilot Randomized Controlled Trial. Nutrients, 17(15), 2541. https://doi.org/10.3390/nu17152541