This clinical trial evaluates the effect of Golden Rice cookies enriched with Piper crocatum (red betel leaf) extract on lipid profile control in patients with type 2 diabetes mellitus. The intervention is designed as a short-term, food-based strategy to complement existing diabetes management by integrating functional food into daily dietary practice.
The rationale for this approach is based on evidence that beta-carotene from Golden Rice and polyphenols from Piper crocatum exert antioxidant, anti-inflammatory, and lipid-lowering activities. Combining these bioactive compounds in the form of cookies provides a culturally acceptable, affordable, and practical dietary intervention. The cookie format was selected due to its high acceptance, ease of distribution, and potential to improve adherence compared with capsule or extract preparations.
This trial uses a controlled pre-post design to compare changes in lipid biomarkers between the intervention and control groups over 28 days. Key outcomes include serum levels of LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol. The study also explores potential synergistic effects on oxidative stress and inflammatory processes associated with dyslipidemia in diabetes.
By translating the concept of functional food into a practical dietary item, this study aims to generate evidence for its role as an adjunctive therapy in diabetes care. Findings are expected to inform future dietary guidelines and nursing interventions, particularly in community-based settings where accessibility, patient adherence, and cost-effectiveness are critical considerations.
