Understanding Artificial Pancreas Systems: Results from a 24-Month Trial

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Non-randomized (moderate): Randomization not used or not reported

Open-label or unblinded (moderate): No blinding reported

Participants on VLCKD had substantial weight reduction over 3 months, around 15% from baseline, similar in magnitude to MedKD.

BMI decreased markedly in the VLCKD group during the intervention period, consistent with large body weight reduction.

Waist circumference improved significantly from baseline in VLCKD, indicating reduced central adiposity.

HOMA-IR declined in VLCKD, showing improved insulin resistance, though the between-group interaction favored MedKD and baseline imbalance limits certainty.

LDL cholesterol showed a downward trend in VLCKD without a significant difference versus MedKD.

HDL changed only slightly during VLCKD and between-group differences were not significant.

Triglycerides decreased within VLCKD, with no statistically clear superiority versus MedKD.

Total cholesterol trended lower after VLCKD, with similar overall pattern to MedKD.

HbA1c fell modestly in VLCKD, with no significant between-group difference.

Fasting glucose improved in VLCKD; between-group comparison showed no clear significant difference.

Formula-based ketogenic program (600-800 kcal/day) using meal replacements, carbohydrate ≤50 g/day, medically supervised.

MedKD produced substantial weight reduction over 3 months, approximately 15%, comparable to VLCKD.

BMI decreased significantly in MedKD, mirroring the marked body weight reduction.

Waist circumference improved significantly in MedKD, indicating better central adiposity markers.

HOMA-IR improved in MedKD, with a larger between-group time interaction versus VLCKD, though baseline imbalance adds uncertainty.

LDL trended downward in MedKD without a significant difference versus VLCKD.

HDL remained largely stable in MedKD, and between-group differences were not significant.

Triglycerides decreased in MedKD, with only a trend toward greater improvement versus VLCKD.

Total cholesterol declined modestly in MedKD, with no significant differential effect versus VLCKD.

HbA1c decreased modestly in MedKD, without significant between-group difference.

Fasting glucose declined in MedKD, with a trend toward larger improvement but without confirmed strong between-group difference.

Creatinine increased slightly in MedKD while decreasing in VLCKD, but all values remained in physiologic range and clinical impact was unclear.

Whole-food ketogenic Mediterranean-style diet (typically 1200-1500 kcal/day), carbohydrate <50 g/day, emphasizing vegetables, olive oil, fish, eggs, nuts, and minimal processed foods.

Positive: 18; Negative: 0; No effect: 2; Mixed: 0

Direction counts recalculated from intervention outcomes due to mismatch with AI-provided counts.

Extracted 21 outcome signals across the study

Most metabolic and anthropometric outcomes improved in both interventions, with no clear evidence of harm and no severe adverse events.

Direction counts were recalculated from extracted outcomes because the AI-provided totals did not match.

↓ Body weight by about 15% in both diet groups

Mostly intermediate or surrogate outcomes

A whole-food Mediterranean ketogenic approach can deliver short-term weight loss similar to VLCKD in clinical practice

Both ketogenic strategies improved central adiposity and insulin resistance over 3 months

Preference-based personalized diet selection may be feasible while maintaining substantial metabolic benefit

Masi D, Spizzichini ML, Colonnello E, et al. Personalizing Obesity Treatment: Real-World Comparison of a Very-Low-Calorie Ketogenic Diet Versus a Whole-Food Mediterranean Ketogenic Diet. Metabolites. 2026;16(4):248. doi:10.3390/metabo16040248

Non-randomized, preference-based allocation introduces selection bias

Baseline imbalances existed, including higher diabetes prevalence and HOMA-IR in MedKD

Short 3-month follow-up limits long-term durability conclusions

No quantitative food intake tracking or standardized adherence score

In adults with obesity, a whole-food Mediterranean ketogenic diet achieved about 15% weight loss in 3 months, similar to a very-low-calorie ketogenic diet, with comparable metabolic improvements and no severe adverse events.

↓ Waist circumference and waist-to-height ratio in both groups

↓ Insulin resistance (HOMA-IR) in both groups; larger drop in MedKD

≈ Similar lipid profile changes between VLCKD and MedKD

Includes self-reported outcomes (moderate): Self-reported outcomes used

No post-intervention follow-up (moderate): 0 weeks of follow-up after treatment ended

Non-randomized study (moderate): Randomization not reported or not used

Open-label or unblinded study (moderate): No blinding reported

Mediterranean ketogenic eating matched VLCKD for weight loss over 3 months

This real-world 3-month study compared two ketogenic strategies in adults with obesity: a meal-replacement very-low-calorie ketogenic diet and a whole-food Mediterranean ketogenic diet. Both groups lost about 15% of body weight and improved waist measures and insulin resistance. The Mediterranean ketogenic approach performed similarly overall and may offer a more flexible option for personalized care.

Results come from real-world care, not randomized assignment

Both plans were medically supervised and included follow-up support

Metabolic response differences may reflect baseline severity differences

Long-term maintenance beyond 3 months was not evaluated

Real-world 3-month comparison of VLCKD vs whole-food Mediterranean ketogenic diet in adults with obesity

Mediterranean ketogenic eating matched VLCKD for weight loss over 3 months

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