NCT Number: NCT07151833
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.
Trial opening soon.
Get Notified20 year–70 year
All sexes
Interventional
Not applicable
Bantaeng, South Sulawesi, 92411, Indonesia
Andina Setyawati, Dr
PRINCIPAL_INVESTIGATOR
Baucaya Baucaya, BSN
CONTACT
Nuurhidayat Jafar, Dr
SUB_INVESTIGATOR
Syamsul Kamar, BSN
CONTACT
WHIKA FEBRIA DEWATISARI, Dr
SUB_INVESTIGATOR
Type 2 diabetes mellitus is a chronic condition associated with serious complications, including neuropathy and diabetic foot ulcers. Many people in Indonesia still struggle with poor blood sugar control despite standard treatments. This highlights the need for safe, affordable, and culturally acceptable nutritional strategies.
This study is testing GlucoBites, a functional cookie made with Gynura procumbens, a traditional medicinal plant with potential glucose-lowering and vascular protective properties. Researchers want to see if adding GlucoBites to daily care can improve blood sugar control and reduce early risk factors linked to diabetic foot ulcer development.
The study will help determine whether functional food innovation can be integrated into community-based diabetes management and offer a preventive approach to reduce long-term complications.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
Other names: Functional Cookies with 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.
Other names: Placebo cookies
Time frame: Baseline and 12 weeks after intervention
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).
Time frame: Baseline and 12 weeks after intervention
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).
Time frame: Baseline and 12 weeks after intervention
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).
Time frame: Baseline and 12 weeks after intervention
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).
Contact information is provided by the study sponsor or research team.
Andina Setyawati
Other
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
Acronym: GlucoBites
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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