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NOT YET RECRUITING
NCT07151833
NA

GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes

Sponsor: Andina Setyawati

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

GlucoBites (with Gynura procumbens)

Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.

DIETARY_SUPPLEMENT

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