Background/Objectives: The optimal dietary approach for managing glycemic and metabolic control in type 2 diabetes (T2D) is still uncertain, though it should be tailored for clinical settings. Therefore, we sought to assess the impact of a multicomponent nutritional strategy on glycemic control in T2D patients within a public health system. Methods: NUGLIC was an open-label, parallel-group, superiority, multicenter randomized controlled trial. Participants aged 30 and older with poorly controlled T2D were randomly assigned to either (1) a personalized dietary prescription (control group, n = 185) or (2) a strategy involving targeted nutritional advising, mindfulness techniques, and short message services (NUGLIC [intervention] group, n = 186). The primary outcomes were glycated hemoglobin (HbA1c, %) measured after 24 weeks and glycemic control, defined as having an HbA1c > 7% at baseline and achieving ≤7% after follow-up, or having HbA1c ≤ 7% at baseline and reducing the use of glucose-lowering medications post-follow-up. The secondary outcomes included cardiometabolic features, self-care practices, diet quality, and quality of life. Results: A total of 371 participants were included in an intention-to-treat analysis for the primary outcomes. At six months, both groups exhibited a reduction in HbA1c levels compared to the baseline (NUGLIC group: −0.6% [95% confidence interval (CI) −0.9; −0.3], p < 0.001; control group: −0.5% [95% CI −0.7; −0.3], p < 0.001). However, no significant differences were observed between the groups in terms of HbA1c after follow-up (intervention group: 8.1%; control group: 8.3%; difference: −0.2% [95% CI −0.5; 0.1], p = 0.30) or glycemic control (NUGLIC group: 19.9%; control group: 18.9%; odds ratio 0.96 [95% CI 0.56; 1.67], p = 0.89). While the control group showed an improvement in overall diet quality, no significant differences emerged between the groups by the end of this study (p = 0.13). There were also no significant differences in other secondary outcomes nor in the use of glucose-lowering medications and adverse events after follow-up. Conclusions: The multicomponent nutritional strategy did not demonstrate superiority over personalized dietary prescriptions in achieving glycemic control for participants with poorly managed T2D. In this sense, both nutritional interventions could be used in clinical practice to improve HbA1c levels, considering the profile and preferences of individuals.

Background/Objectives: Familial hypercholesterolemia (FH) is an increasingly common inherited disorder that increases cardiovascular risk. Despite the importance of lifestyle interventions, adherence to a healthy diet among individuals with FH remains suboptimal. This pilot, multicenter, double-blind, placebo-controlled randomized trial aimed to evaluate the feasibility and preliminary effects of a culturally adapted cardioprotective diet (DICA-FH), alone or in combination with phytosterol and/or krill oil supplementation, on lipid parameters in Brazilian adults with probable or definitive FH. Methods: Between May and August 2023, 58 participants were enrolled across nine Brazilian centers and randomized (1:1:1:1) into four groups: DICA-FH + phytosterol placebo + krill oil placebo; DICA-FH + phytosterol 2 g/day + krill oil placebo; DICA-FH + phytosterol placebo + krill oil 2 g/day; and DICA-FH + phytosterol 2 g/day + krill oil 2 g/day. Interventions lasted 120 days. The primary outcomes were mean low-density lipoprotein cholesterol (LDL-c) and lipoprotein(a) (Lp[a]) levels, as well as adherence to treatment at follow-up. Secondary outcomes included mean levels of other lipids, frequency of adverse events, and assessment of protocol implementation components. All data were presented separately for the allocation groups: phytosterol vs. placebo and krill oil vs. placebo. Results: Mean age was 54.5 ± 13.7 years, and 58.6% were women. Both adherence to protocol (91.8% attendance; 79.1% investigational product intake) and retention (86.2%) were high. No significant differences between groups were found for LDL-c or Lp(a). However, regardless of allocation to active supplementation or placebo, a significant reduction in Lp(a) concentrations was observed following the DICA-FH intervention (median difference: −3.8 mg/dL [interquartile range: −7.5 to −1.2]; p < 0.01). Significant reductions in oxidized LDL (LDL-ox) and LDL-ox/LDL-c ratio were also observed in the overall sample (p < 0.01). Although not statistically significant, all groups showed improvements in diet quality after 120 days. No serious adverse events related to the interventions were reported. Additionally, most protocol implementation components were successfully achieved. Conclusions: The DICA-FH strategy, with or without supplementation, was safe and well-tolerated. Although not powered to detect clinical efficacy (which is acceptable in exploratory pilot trials), the study supports the feasibility of a larger trial and highlights the potential of dietary interventions in the management of HF.

Background: A healthy diet is essential to reduce cardiovascular disease (CVD) risk and mortality. However, recent studies lack conclusive evidence on the affordability of cardioprotective diets worldwide. The Brazilian Cardioprotective Nutritional Program Trial (BALANCE Program) is a randomized multicenter clinical trial that proposes regionally adapted cardioprotective diet that achieves nutritional recommendations and incorporates accessible and affordable foods. The study aim is to analyze cost-effectiveness of the BALANCE Program in comparison to generic dietary advice for individuals, based on diet costs and nutritional quality among patients with high adherence to the study protocol in both control and intervention groups. Methods: We conducted a cost-effectiveness analysis of subsample from the BALANCE Program (1,161 individuals with previous event of CVD and high adherence to study protocol enrolled in 35 research sites throughout Brazil) after a 3-year follow-up. Direct costs and nutritional quality of diets reported by participants were estimated at the individual level. Diet costs were based on market prices collected from five major supermarket chains. Effectiveness was measured in terms of diet quality, according to adherence to the Brazilian Health Eating Index Revised (BHEI-R). Mean differences were compared between groups using generalized estimating equation. Monte Carlo simulations were performed to comprise probabilistic sensitivity analysis regarding trends in the comparison between groups. Results: At baseline, mean direct diet costs were equal (U$3.9/day), and there were small differences in BHEI-R between groups (53.5 points in BALANCE Program, and 51.8 points in control group). After the 3-year follow-up, the intervention was associated with a mean cost saving of U$0.31/day (95%CI: -0.59; -0.04) and mean BHEI-R increase of 4.38 (95%CI: 2.81; 5.95). The intervention was dominant strategy in terms of cost-effectiveness due to higher effectiveness at lower costs in comparison with the control group. Conclusions : There was a statistically significant effect of the intervention regarding increase in diet quality and reduction in cost after 3 years compared to the control group. The BALANCE intervention may be an option to improve diet quality with lower costs among Brazilians with CVD. Trial registration NCT01620398. Registered June 2012. https://clinicaltrials.gov/ct2/show/NCT01620398