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GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
Sponsor: Andina Setyawati
Summary
The goal of this randomized controlled trial is to learn if GlucoBites functional cookies containing Gynura procumbens can help improve blood sugar control and lower the risk of diabetic foot ulcers in adults with type 2 diabetes. The main questions are: * Do GlucoBites cookies lower fasting blood glucose and HbA1c? * Do GlucoBites cookies improve insulin resistance and vascular health? * Can GlucoBites reduce early signs that may lead to diabetic foot ulcers? Researchers will compare: * Intervention group: participants will eat 4 GlucoBites cookies every day for 12 weeks. * Control group: participants will continue standard diabetes care without GlucoBites. Participants will: * Visit the community health center for blood tests and foot health checks. * Be monitored for blood sugar, insulin resistance, lipid profile, and vascular function. * Be assessed for early risk of diabetic foot ulcer development. This study will help determine if a functional food innovation can support diabetes care and prevent complications.
Official title: Efficacy of GlucoBites Functional Cookies Containing Gynura Procumbens on Glycemic Control, Insulin Resistance, and Prevention of Diabetic Foot Ulcer Risk in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2025-09-20
Completion Date
2026-01-20
Last Updated
2025-09-03
Healthy Volunteers
No
Interventions
GlucoBites (with Gynura procumbens)
Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
Control Cookies (without Gynura procumbens)
Participants consume 4 cookies per day for 12 weeks. The cookies are identical in packaging, size, weight, and flavor to the GlucoBites cookies but do not contain Gynura procumbens.
Locations (1)
Public Health Centre of Campagaloe
Bantaeng, South Sulawesi, Indonesia