Five-year patient-reported outcomes of individualized nutrition therapy supporting nutritional ketosis in adults with type 2 diabetes.

INTRODUCTION

Sleep disturbance, depressive symptoms, and musculoskeletal pain are common in type 2 diabetes (T2D). The long-term patient-reported effects of nutrition-based interventions targeting metabolic dysfunction remain unclear. We examined 5-year changes in sleep, depressive symptoms, and knee pain in adults with T2D participating in a digitally delivered continuous care intervention providing individualized nutrition therapy supporting nutritional ketosis.

METHODS

Adults with T2D enrolled in the intervention arm of a non-randomized clinical trial were followed for 5 years (N = 194). Sleep was assessed using the Pittsburgh Sleep Quality Index (PSQI), depressive symptoms with the Center for Epidemiologic Studies Depression Scale (CES-D), and knee outcomes with the Knee Injury and Osteoarthritis Outcome Score (KOOS). Linear mixed-effects models evaluated change over time in the full cohort and symptom-defined subgroups. Clinical thresholds and minimal clinically important differences (MCID) were also examined.

RESULTS

PSQI scores improved at all follow-ups, with 19-25% reductions from baseline to 5 years; the proportion classified as poor sleepers decreased from 63 to 48%. Depressive symptoms decreased by 10 weeks and were sustained through 2 years; at 5 years the full cohort returned to baseline, but participants with baseline elevations maintained scores below the screening cut-off. KOOS subscales improved significantly; among those with baseline weekly knee pain, 57-74% exceeded the 10-point MCID.

DISCUSSION: A low-carbohydrate nutrition-focused, digital program targeting T2D was associated with durable sleep and pain benefits and sustained mood gains in symptomatic participants over 5 years.