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Human trials

Keto-Med: glucose and lipids tell different stories

Effect of a ketogenic diet versus Mediterranean diet on glycated hemoglobin in individuals with prediabetes and type 2 diabetes mellitus: The interventional Keto-Med randomized crossover trial

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PLAIN-LANGUAGE SUMMARY

What it found

The primary HbA1c comparison did not show a clear difference (P = 0.11). Mean triglyceride changes were −16% versus −5%, while LDL cholesterol changed +10% versus −5%, for ketogenic versus Mediterranean-plus diets. These are relative changes from baseline.

Keep these limits in view

Small complete-case analysis, medication adjustments, COVID-19 disruptions, and no washout complicate interpretation. Some sensitivity analyses favored keto. Secondary comparisons lacked multiplicity adjustment. The registry now lists a larger overall enrollment than this publication cohort.

Understand the context

Evidence type
Randomized crossover dietary trial
Population or scope
Adults with prediabetes or type 2 diabetes; primary-analysis participants were aged 41–77
Sample or coverage
Publication cohort: 42 randomized, 40 started, 33 with complete primary-outcome data
Study duration or data period
Planned 12 weeks per diet, then 12 weeks of follow-up; some phases extended during COVID-19
Comparison
Ketogenic versus Mediterranean-plus diets; both emphasized nonstarchy vegetables and avoiding added sugars and refined grains. No washout.
Measured outcomes
Primary: relative HbA1c change. Secondary: blood lipids and other metabolic measures. CGM outcomes were exploratory. ApoB was not reported and LDL particle size was not measured.

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