GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GlucoBites (with Gynura procumbens), Control Cookies (without Gynura procumbens).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus, Diabetic Neuropathy. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Primary outcome measures
- Fasting Blood Glucose (FBG) [Time frame: Baseline and 12 weeks after intervention]
- Change in HOMA-IR [Time frame: Baseline and 12 weeks after intervention]
- MMP-9/TIMP-1 Ratio [Time frame: Baseline and 12 weeks after intervention]
- Ankle-Brachial Index (ABI) [Time frame: Baseline and 12 weeks after intervention]
Eligibility criteria
Inclusion criteria
- 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).
- Willing to consume study cookies and comply with study protocol.
- Provided written informed consent.
Exclusion criteria
- 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.
- Known allergy to ingredients in study cookies.
- Participation in another clinical trial within the last 3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Indonesia · 1 center
- Public Health Centre of Campagaloe — Bantaeng
Identifiers
NCT: NCT07151833 · GlucoBites-DM2-2025 · 02209/UN4.22/PT.01.03/2025