Ultra-processed food reduction in cardiac rehabilitation: a novel complementary pathway to enhance diet quality and cardiometabolic health

Background Intakes of ultra-processed foods (Nova 4) have been consistently associated with type 2 diabetes (T2D), obesity, and cardiovascular diseases. The DIABEPIC-1 and -2 pilot trials, combining structured cardiac rehabilitation and targeted nutritional intervention for 6 months, showed high completion rates and promising remission rates for prediabetes, T2D, and metabolic syndrome, as well as significant reductions in waist circumference and body mass. Purpose This secondary, exploratory analysis examined the associations between changes from baseline to 6 months in unprocessed/minimally processed foods (Nova 1) and Nova 4 intakes and their impact on the changes in nutritional, anthropometric, and metabolic outcomes, as well as disease remission. Methods Data were pooled from DIABEPIC-1 and -2 trials. It included 47 participants with prediabetes or T2D who completed a cardiac rehabilitation training program and attended 6 nutritional sessions focused on implementing a Mediterranean diet, lowering Nova 4 intake, and following a time-restricted eating protocol. Dietary intake was assessed using 3-day food diaries with the Keenoa app, and energy intake from foods (%kcal) was classified as per the Nova system. Outcomes included body composition (bioelectrical impedance), biochemical markers, and disease remission, defined as reaching target cardiometabolic health markers at 3 months and maintaining them at 6 months, without medication. Repeated-measures ANOVA, linear regression, and logistic regression models (adjusted for age, sex, BMI change, and change in Mediterranean diet adherence) were applied. Results From baseline to 6 months, mean daily energy intake was reduced by 211 kcal (95% CI: -377 to -44 kcal; p=0.009), while we observed a 10% reduction (-15 to -5%; p<0.001) in Nova 4 intakes and a 9% increase (3 to 15%; p <0.001) in Nova 1 intakes. Significant improvements in diet quality included lower sugars (–15 g/day; -23 to -6 g/day; p<0.001), sodium (–20%; -40 to -10%; p< 0.001), and omega-6/3 ratio (–40%; -50 to -20%; p<0.001), with omega-3 intake nearly doubling (+90%; 40 to 170%; p<0.001). A 10% reduction of Nova 4 intake from baseline to 6 months was associated with favorable changes in omega-3 intake (+0.47 g, 0.05 to 0.90 g; p=0.030). The odds ratios for T2D and metabolic syndrome remission were 3.10 (0.26 to 36.96; p=0.372) and 2.07 (0.65 to 6.60; p=0.217), respectively, with a 10% reduction of Nova 4 intake. Conclusion A 6-month multidisciplinary lifestyle intervention including a novel intervention to reduce ultra-processed foods was associated with improved diet quality, metabolic profile, and disease remission. Reducing Nova 4 and increasing Nova 1 may offer complementary pathways to improve cardiometabolic health. Larger randomized trials are warranted to confirm these findings.