NCT07151833Not yet recruiting
GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 22 Aug 2025
- Start date
- 20 Sept 2025
- Primary completion date
- 20 Dec 2025
- Lead sponsor
- Andina Setyawati
- Diseases
- Type 2 diabetes
- NCT number
- NCT07151833
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 20 Sept 2025 to the primary completion date, 20 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of active diabetic foot ulcer or severe infection.
- Known allergy to ingredients in study cookies.
Lab values
- Severe cardiovascular, renal (eGFR \< 30 mL/min/1.73 m²), or hepatic impairment.
Other
- Current use of herbal supplements or functional foods containing Gynura procumbens.
- Pregnancy or breastfeeding.
- Participation in another clinical trial within the last 3 months.
Who the study is looking for
- 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.
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Public Health Centre of Campagaloe Coordinator of this site? Confirm its status | Bantaeng | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.