GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
NCT ID: NCT07151833
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
126 participants
INTERVENTIONAL
2025-09-20
2026-01-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control Cookies (without Gynura procumbens)
Participants receive 4 cookies per day for 12 weeks. The cookies are identical in packaging, size, weight, and flavor but do not contain Gynura procumbens.
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.
GlucoBites (with Gynura procumbens)
Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
GlucoBites (with Gynura procumbens)
Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
Interventions
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GlucoBites (with Gynura procumbens)
Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
70 Years
ALL
No
Sponsors
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Andina Setyawati
OTHER
Responsible Party
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Andina Setyawati
Principal Investigator
Locations
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Public Health Centre of Campagaloe
Bantaeng, South Sulawesi, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Original research article reporting the antidiabetic effects of Gynura procumbens on pancreatic histopathology via caspase family expression in diabetic rat models, published in the Journal of Pharmacy \& Pharmacognosy Research (2025).
Other Identifiers
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02209/UN4.22/PT.01.03/2025
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GlucoBites-DM2-2025
Identifier Type: -
Identifier Source: org_study_id
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