Nurse-Led Functional Nutrition Care Model (FUNCARE): Integrating Biologic and Behavioral Nursing Approaches to Improve Glycemic Outcomes in Type 2 Diabetes
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background Functional foods may complement nurse-led diabetes care. Gynura procumbens, a flavonoid-rich plant with antihyperglycemic and vasoprotective potential, was incorporated into a nurse-led functional nutrition care model (FUNCARE) for adults with type 2 diabetes mellitus (T2DM). Objective To evaluate the glycemic and vascular effects, acceptability, and safety of G. procumbens-enriched cookies delivered within FUNCARE.. Methods In this randomized, placebo-controlled, four-arm trial, 246 adults with T2DM from five community health centers received placebo cookies or cookies containing 5%, 10%, or 20% G. procumbens extract. All participants consumed two cookies daily for 12 weeks and received standardized nurse-led coaching. Outcomes included fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), HOMA-IR, ankle-brachial index (ABI), and MMP-9/TIMP-1 ratio. Week-12 outcomes were analyzed by ANCOVA adjusted for baseline values, body mass index, and diabetes duration, with Dunnett-adjusted contrasts versus placebo. Results No significant treatment-group effect was observed for FPG (p = 0.61). HbA1c differed significantly across groups (p < 0.001); versus placebo, adjusted HbA1c was lower by 0.59 percentage points in the 5% group (95% CI, −1.01 to −0.17; p=0.006), 0.84 in the 10% group (95% CI, −1.26 to −0.42; p < 0.001), and 2.13 in the 20% group (95% CI, −2.56 to −1.70; p < 0.001). HOMA-IR was significantly lower than placebo in the 10% and 20% groups (both p < 0.001). Treatment-group effects were also significant for ABI (p = 0.004) and MMP-9/TIMP-1 ratio (p < 0.001). Adherence exceeded 90%, acceptability was 96%, and no serious adverse events occurred. Conclusions Within standardized nurse-led care, G. procumbens-enriched cookies were associated with lower HbA1c, and lower HOMA-IR versus placebo, whereas FPG was unchanged; selected vascular outcomes also differed. Because all groups received the same nurse-led coaching, the independent effect of FUNCARE could not be determined. Clinical Trial Registry number and website where it was obtained https://clinicaltrials.gov/study/NCT07151833.
Institutions: Indonesia Open University, Universitas Sumatera Utara
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $5,000
OpenAlex ID: W7222844072