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.
Adults aged 20-70 years.
Diagnosed with type 2 diabetes mellitus (T2DM) based on ADA criteria.
HbA1c ≥ 7%.
At risk of diabetic foot ulcer (ABI < 0.9 or early neuropathy signs).
Current use of herbal supplements or functional foods containing Gynura procumbens.
Presence of active diabetic foot ulcer or severe infection.
Severe cardiovascular, renal (eGFR < 30 mL/min/1.73 m²), or hepatic impairment.
Pregnancy or breastfeeding.
Parallel
GlucoBites (with Gynura procumbens)
Dietary supplementParticipants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
Control Cookies (without Gynura procumbens)
Dietary supplementParticipants 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.
Fasting Blood Glucose (FBG)
Fasting blood glucose (FBG, mg/dL) measured from venous blood after 8-10 hours of fasting using standardized laboratory methods. The primary endpoint is the change from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Change in HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose (mg/dL) and fasting insulin (µIU/mL) using the formula: \[fasting insulin × fasting glucose / 405\]. The endpoint is the change in HOMA-IR from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
MMP-9/TIMP-1 Ratio
The ratio of matrix metalloproteinase-9 (MMP-9) to tissue inhibitor of metalloproteinase-1 (TIMP-1) in serum, quantified using ELISA. The ratio is calculated by dividing MMP-9 (ng/mL) by TIMP-1 (ng/mL). The endpoint is the change in MMP-9/TIMP-1 ratio from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Ankle-Brachial Index (ABI)
The ankle-brachial index (ABI) is calculated as the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Measurements are obtained using a handheld Doppler device. ABI will be used as an indicator of peripheral vascular function and early risk of diabetic foot ulcer. The endpoint is the change in ABI from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
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Andina Setyawati
Lead sponsor
Hasanuddin University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
