Nutrition, Genetics, and Disease · Journal article
Nutrients · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This uncontrolled observational study reports that an 8-week sequential ketogenic protocol followed by carbohydrate reintroduction (KETOCOMP) produced meaningful reductions in body weight, BMI, and fat mass in patients who had failed to respond adequately to a Mediterranean diet. No serious adverse events were documented, and markers of muscle loss (BCM, PhA) were stable, though fat-free mass decreased significantly. The findings are promising but lack a comparator group and longer-term safety data, and the authors themselves acknowledge the need for larger controlled trials before clinical adoption can be recommended.
Longitudinal, observational cohort study without control arm. Adult patients with obesity/overweight and metabolic comorbidities, previously non-responsive to a hypocaloric Mediterranean diet. Intervention: Food-based sequential ketogenic nutritional protocol: 4-week ketogenic phase (approximately 1200 kcal/day, <20 g carbohydrate) followed by 4-week low-carbohydrate reintroduction phase (approximately 1300 kcal/day, up to 100 g carbohydrate)….
Across entire pathway (T0–T3), body weight decreased 7.7%, BMI 9.45%, and fat mass 23.1% Using post-Mediterranean diet baseline (T1–T3), mean body weight decreased 7.79 kg and fat mass 6.29 kg During ketogenic phase alone (T1–T2), body weight decreased 6.10 kg and fat mass 4.80 kg
Short 8-week follow-up; long-term sustainability and safety unknown Discontinuation rates could not be assessed due to cohort selection criteria
The KETOCOMP protocol may offer a structured second-line option for patients resistant to conventional Mediterranean dieting; the preservation of body cell mass and phase angle is reassuring for short-term safety, but clinicians should recognize that this is preliminary evidence from a small, uncontrolled setting and should not yet replace established weight loss interventions without larger controlled data.
Real-world observational study without control group showing body composition changes in Mediterranean diet non-responders; single-centre, uncontrolled design with short 8-week follow-up limits evidence strength despite positive signals.
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Quoted from the source exactly as published.
The KETOCOMP protocol may offer a structured second-line option for patients resistant to conventional Mediterranean dieting; the preservation of body cell mass and phase angle is reassuring for short-term safety, but clinicians should recognize that this is preliminary evidence from a small, uncontrolled setting and should not yet replace established weight loss interventions without larger controlled data.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Background: Obesity is a complex, chronic disease with metabolic complications. Many patients respond suboptimally to conventional interventions like the hypocaloric Mediterranean diet (MD), highlighting the need to investigate alternative supervised nutritional strategies in patients with an insufficient response to conventional dietary treatment. Objectives: This study aimed to evaluate the KETOCOMP (Food-Based KETOgenic Nutritional Protocol for Patients with COMPlicated Obesity), a medically and dietitian-supervised, food-based sequential ketogenic nutritional protocol consisting of a ketogenic phase followed by controlled carbohydrate reintroduction, for improving anthropometric and body composition in patients with complicated obesity who were non-responsive to conventional dietary treatment. Methods: In this longitudinal, observational study, adult patients with obesity/overweight and metabolic comorbidities, previously non-responsive to a hypocaloric MD, were identified. Patients followed a 4-week food-based ketogenic diet (approx. 1200 kcal/day, <20 g carbohydrate, CHO) followed by a 4-week low-carbohydrate reintroduction phase (approx. 1300 kcal/day, up to 100 g CHO). Anthropometric and body composition parameters were assessed at baseline (T0), after the MD (T1), after the ketogenic phase (T2), and after the low-carbohydrate phase (T3). Intra-subject comparisons were performed. Results: Across the entire observed nutritional pathway (T0–T3), body weight (BW), body mass index (BMI), and fat mass (FM) decreased by 7.7%, 9.45%, and 23.1%, respectively. Using T1 as the relevant baseline for the second-line KETOCOMP sequence, mean BW and FM decreased by 7.79 kg and 6.29 kg, respectively, from T1 to T3; during the ketogenic phase alone (T1–T2), BW decreased by 6.10 kg and FM by 4.80 kg. Body Cell Mass (BCM) and Phase Angle (PhA) showed no statistically significant changes during the ketogenic and carbohydrate-reintroduction phases, whereas Fat-Free Mass (FFM) decreased significantly. Significant reductions in waist and hip circumferences (WC, HC) were also observed. No serious adverse events were documented among included participants; however, discontinuation rates could not be assessed because completion through T2 formed part of cohort selection. Conclusions: The KETOCOMP protocol may represent a clinically applicable second-line nutritional strategy for patients with obesity and metabolic complications who respond suboptimally to conventional dietary treatment. The observed reductions in body weight and fat mass, together with the absence of significant changes in BCM and PhA, suggest a favorable short-term change in body composition. However, larger prospective controlled studies incorporating standardized clinical and biochemical safety monitoring and direct assessment of skeletal muscle are required to confirm these findings and evaluate longer-term outcomes.
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