Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07151833
Brief 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.
Detailed Description:
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.
Study:
NCT07151833
Study Brief:
Protocol Section:
NCT07151833