Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Sample
2.3. Dietary Intervention
2.4. Adherence
2.5. Safety Monitoring
2.6. Study Outcomes
2.6.1. Body Mass Index (BMI)
2.6.2. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
2.6.3. EuroQoL-5 Dimensions (EQ-5D)
2.6.4. The 36-Item Short Form Health Survey (SF-36)
2.7. Statistical Analysis
2.8. Ethical Considerations
3. Results
3.1. Characteristics of Patients
3.2. Adherence to VLCKD
3.3. Safety
3.4. Efficacy
3.4.1. Change in BMI
3.4.2. Change in Total WOMAC
3.4.3. Change in Each WOMAC Domain
3.4.4. Change in EQ-5D
3.4.5. Change in SF-36
3.4.6. Association over Time between BMI and Patient-Reported Outcomes
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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Inclusion Criteria |
---|
Age ≥ 18 years and ≤65 years |
AND |
Symptomatic knee osteoarthritis according to the American College of Rheumatology criteria [45] |
AND |
History of failure to achieve weight loss with standard hypocaloric diets |
AND |
|
OR |
|
Exclusion Criteria |
|
Characteristics | Patients (n = 16) |
---|---|
Age, years, mean ± SD | 57.3 ± 5.5 |
BMI, kg/m2, mean ± SD | 40.0 ± 4.8 |
BMI > 35, n (%) | 13 (81) |
Comorbidities | |
Hypertension, n (%) | 9 (56) |
Hyperlipidemia, n (%) | 8 (50) |
Non-alcoholic fatty liver disease, n (%) | 5 (31) |
Polycystic ovary syndrome, n (%) | 1 (6) |
Type 2 diabetes, n (%) | 1 (6) |
Previous atherothrombotic events, n (%) | 1 (6) |
Congestive heart failure, n (%) | 0 |
Neurodegenerative disorders, n (%) | 0 |
Medications | |
Non-steroidal anti-inflammatory drugs, n (%) | 6 (38) |
Paracetamol, n (%) | 9 (56) |
Patient-reported outcomes | |
Total WOMAC, mean ± SD | 43.6 ± 16.9 |
WOMAC pain, mean ± SD | 8.0 ± 3.1 |
WOMAC stiffness, mean ± SD | 4.2 ± 1.9 |
WOMAC function, mean ± SD | 31.3 ± 13.0 |
EQ-5D utility score, mean ± SD | 0.72 ± 0.32 |
EQ-5D VAS, mean ± SD | 54.9 ± 24.0 |
SF-36 MCS, mean ± SD | 53.6 ± 23.7 |
SF-36 PCS, mean ± SD | 46.2 ± 24.8 |
Patient | Time Point of the Study | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | T8 | T12 | |
OA1 | ● | ● | ●● | ●● | ● | ● | ||||
OA3 | ● | ● | ●● | ● | ● | |||||
OA4 | ●● | ●● | ●●● | ●●● | ●● | ● | ||||
OA5 | ● | ●● | ● | ●● | ● | ● | ● | |||
OA6 | ● | ● | ● | ● | ●● | ●● | ● | ● | ||
OA7 | ● | ●● | ●●● | ●● | ●● | ● | ●● | ● | ● | |
OA9 | ● | ● | ●● | ● | ● | ● | ||||
OA10 | ● | ●● | ● | ●● | ●● | ● | ● | |||
OA11 | ● | ● | ● | ●● | ●● | ●● | ● | ● | ● | |
OA12 | ● | ● | ●● | ●●● | ●●● | ● | ● | ● | ||
OA14 | ● | ● | ● | ●● | ● | ●● | ● | |||
OA15 | ● | ● | ●● | ● | ● | ● | ● | |||
OA16 | ●● | ●●● | ●●● | ●● | ●● | ● | ● | |||
OA17 | ● | ● | ● | ● | ● | ● | ● | ● | ||
OA19 | ● | ● | ●● | ● | ● | ● | ||||
OA20 | ● | ●● | ●●● | ● | ● | ● | ||||
Amount of ketones in the urine: | absent | ● small | ●● moderate | ●●● large |
β Coefficient (95% CI) | p-Value | |
---|---|---|
Outcome: total WOMAC index over time | ||
BMI | 1.43 (0.29 to 2.58) | 0.014 |
Outcome: WOMAC pain over time | ||
BMI | 0.26 (−0.17 to 0.54) | 0.066 |
Outcome: WOMAC stiffness over time | ||
BMI | 0.12 (0.00 to 0.23) | 0.044 |
Outcome: WOMAC function over time | ||
BMI | 1.07 (0.26 to 1.89) | 0.010 |
Outcome: EQ-5D utility score over time | ||
BMI | −0.01 (−0.17 to 0.00) | 0.055 |
Outcome: EQ-5D VAS score over time | ||
BMI | −1.74 (−3.09 to −0.39) | 0.012 |
Outcome: SF-36 MCS over time | ||
BMI | −1.35 (−3.15 to 0.45) | 0.140 |
Outcome: SF-36 PCS score over time | ||
BMI | −3.25 (−4.65 to −1.84) | <0.001 |
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Ciaffi, J.; Mancarella, L.; Pederzani, G.; Lisi, L.; Brusi, V.; Pignatti, F.; Ricci, S.; Vitali, G.; Faldini, C.; Ursini, F. Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study. Nutrients 2024, 16, 3236. https://doi.org/10.3390/nu16193236
Ciaffi J, Mancarella L, Pederzani G, Lisi L, Brusi V, Pignatti F, Ricci S, Vitali G, Faldini C, Ursini F. Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study. Nutrients. 2024; 16(19):3236. https://doi.org/10.3390/nu16193236
Chicago/Turabian StyleCiaffi, Jacopo, Luana Mancarella, Giulia Pederzani, Lucia Lisi, Veronica Brusi, Federica Pignatti, Susanna Ricci, Giorgia Vitali, Cesare Faldini, and Francesco Ursini. 2024. "Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study" Nutrients 16, no. 19: 3236. https://doi.org/10.3390/nu16193236
APA StyleCiaffi, J., Mancarella, L., Pederzani, G., Lisi, L., Brusi, V., Pignatti, F., Ricci, S., Vitali, G., Faldini, C., & Ursini, F. (2024). Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study. Nutrients, 16(19), 3236. https://doi.org/10.3390/nu16193236