Adaptive Ketogenic-Mediterranean Protocol (AKMP) in Real Clinical Practice: 14-Week Pre-Post Cohort Study on...

Overweight and obesity are associated with insulin resistance, atherogenic dyslipidemia, and low-grade inflammation. We evaluated analytical safety and within-person metabolic changes under the Adaptive Ketogenic-Mediterranean Protocol (AKMP) in real-world practice.

Single arm, prospective pre-post cohort. We enrolled 112 adults; 105 completed 14 weeks of AKMP (12 in nutritional ketosis ≤ 20 g carbohydrate/day + 2 of gradual reintroduction). Fasting venous samples were analyzed in accredited laboratories (glycolipid profile, hepatic-renal function, inflammatory markers; insulin, thyroid hormones, cortisol). HOMA-IR, TyG, and remnant cholesterol (RC) were calculated; body composition was measured by segmental bioimpedance. Paired analyses were used, with hierarchical gatekeeping for the conditional co-primary outcome and prespecified Δ~Δ correlations.

HOMA-IR -52.8% (Δ -1.80; p < 0.001) and RC -35.1% (Δ -10.64 mg/dL; p < 0.001); fasting glucose -13.7 mg/dL, insulin -5.9 μU/L; TyG -0.23 and TG/HDL-c -1.21 (all p < 0.001). Lipids: TG -35.1% and LDL-c -11.2%; HDL-c remained stable. Anthropometry: weight -14.85 kg (-14.7%) and trunk fat -4.88 kg (-22.2%) (p < 0.001).

no serious adverse events; GGT -47.0%, eGFR +11.0%, and CRP -24.6% (p < 0.001). Prespecified correlations supported the internal consistency of the glycolipid axis (e.g., ΔHOMA-IR~ΔTyG; ΔRC~ΔHOMA-IR).

In adults with overweight or obesity, the AKMP was associated with improvements in the glucose-insulin axis, atherogenic profile (RC, TG/HDL-c, TG), and body composition, while maintaining a favorable safety profile. The protocol appears feasible in clinical practice and monitorable with routine laboratory tests, although randomized controlled trials are needed to confirm causality and long-term sustainability.