Zare 2017.
Study characteristics | ||
Methods | Prospective, randomised, non‐blinded, controlled trial to compare MAD to usual care over a 2‐month period. | |
Participants |
|
|
Interventions | Randomised into 1 of 2 groups; MAD (carbohydrates limited to 15 g per day; approximate macronutrient intakes as a percentage of total energy: 4% to 6% carbohydrate, 20% to 30% protein, 60% to 70% fat) and usual care for a 2‐month period. | |
Outcomes |
|
|
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study meaning participants and personnel were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study meaning outcome assessors were not blinded. |
Incomplete outcome data (attrition bias) | Low risk | Study attrition reported and ITT analysis carried out. |
Selective reporting (reporting bias) | Unclear risk | Protocol unavailable. |
Other bias | High risk | Numerical errors with the article. No power calculation stated. Low levels of urinary ketosis achieved, may impact efficacy data. Unknown if baseline period completed prior to commencing diet. |
AED: antiepileptic drug; BMI: body mass index; Fast FD: fasting‐onset ketogenic diet; Grad KD: gradual‐onset ketogenic diet; ITT: intention‐to‐treat; KD: ketogenic diet; MAD: modified Atkins diet; MCT: medium‐chain triglyceride; QALYs: quality‐adjusted life years; SD: standard deviation; sMAD: simplified modified Atkins diet.