Type 2 Diabetes MellitusGlucoBitesNCT07151833
GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
A study testing GlucoBites (with Gynura procumbens) in people with Type 2 Diabetes Mellitus and Diabetic Neuropathy, run by Andina Setyawati at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Neuropathy
- What is being tested?
- GlucoBites (with Gynura procumbens)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Sep 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Public Health Centre of Campagaloe
Bantaeng, South Sulawesi, 92411
Baucaya Baucaya, BSN, +6282393444557, baucaya75@gmail.com
Syamsul Kamar, BSN, +62 82394971423, syamsulkamar81@gmail.com
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Neuropathy
- Being tested
- GlucoBites (with Gynura procumbens), Control Cookies (without Gynura procumbens)
- Keywords
- Diabetes Mellitus Type 2, Functional Food, Gynura procumbens, Glycemic Control, Insulin Resistance, Diabetic Foot Ulcer Prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoBites (with Gynura procumbens)Dietary supplement
Also called Functional Cookies with Gynura procumbens
Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
Control Cookies (without Gynura procumbens)Dietary supplement
Also called Placebo cookies
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Cookies (without Gynura procumbens) | Placebo comparator | 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. Receives: Dietary Supplement: Control Cookies (without Gynura procumbens) |
| GlucoBites (with Gynura procumbens) | Experimental | Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract. Receives: Dietary Supplement: GlucoBites (with Gynura procumbens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose (FBG)
Fasting blood glucose (FBG, mg/dL) measured from venous blood after 8-10 hours of fasting using standardized laboratory methods. The primary endpoint is the change from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Measured: Baseline and 12 weeks after intervention
Change in HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose (mg/dL) and fasting insulin (µIU/mL) using the formula: [fasting insulin × fasting glucose / 405]. The endpoint is the change in HOMA-IR from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Measured: Baseline and 12 weeks after intervention
MMP-9/TIMP-1 Ratio
The ratio of matrix metalloproteinase-9 (MMP-9) to tissue inhibitor of metalloproteinase-1 (TIMP-1) in serum, quantified using ELISA. The ratio is calculated by dividing MMP-9 (ng/mL) by TIMP-1 (ng/mL). The endpoint is the change in MMP-9/TIMP-1 ratio from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Measured: Baseline and 12 weeks after intervention
Ankle-Brachial Index (ABI)
The ankle-brachial index (ABI) is calculated as the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Measurements are obtained using a handheld Doppler device. ABI will be used as an indicator of peripheral vascular function and early risk of diabetic foot ulcer. The endpoint is the change in ABI from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Measured: Baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial uses a parallel assignment model with two study arms. Participants will be randomly allocated to either the intervention group receiving GlucoBites functional cookies containing Gynura procumbens or the control group receiving standard diabetes care. Both groups will be followed simultaneously for 12 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andina Setyawati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andina Setyawati, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151833
- Sponsor's protocol ID
- GlucoBites-DM2-2025
- Other IDs
- 02209/UN4.22/PT.01.03/2025
- Acronym
- GlucoBites
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the published results will be made available in anonymized form. The data will be accessible upon reasonable request to the corresponding investigator after publication, in accordance with ethical approval and institutional policies
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07151833
- Acronym / sponsor ID
- GlucoBites / GlucoBites-DM2-2025
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Neuropathy
- Keywords
- Diabetes Mellitus Type 2, Functional Food, Gynura procumbens, Glycemic Control, Insulin Resistance, Diabetic Foot Ulcer Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Andina SetyawatiUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled trial uses a parallel assignment model with two study arms. Participants will be randomly allocated to either the intervention group receiving GlucoBites functional cookies containing Gynura procumbens or the control group receiving standard diabetes care. Both groups will be followed simultaneously for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control Cookies (without Gynura procumbens) | Placebo comparator | Dietary Supplement: 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. |
| GlucoBites (with Gynura procumbens) | Experimental | Dietary Supplement: GlucoBites (with Gynura procumbens)Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoBites (with Gynura procumbens)Also: Functional Cookies with Gynura procumbensParticipants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract. | Dietary supplement | GlucoBites (with Gynura procumbens) |
| Control Cookies (without Gynura procumbens)Also: Placebo cookiesParticipants 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. | Dietary supplement | Control Cookies (without Gynura procumbens) |
Primary outcome
Fasting Blood Glucose (FBG)
Time frame: Baseline and 12 weeks after intervention
Fasting blood glucose (FBG, mg/dL) measured from venous blood after 8-10 hours of fasting using standardized laboratory methods. The primary endpoint is the change from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Change in HOMA-IR
Time frame: Baseline and 12 weeks after intervention
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose (mg/dL) and fasting insulin (µIU/mL) using the formula: [fasting insulin × fasting glucose / 405]. The endpoint is the change in HOMA-IR from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
MMP-9/TIMP-1 Ratio
Time frame: Baseline and 12 weeks after intervention
The ratio of matrix metalloproteinase-9 (MMP-9) to tissue inhibitor of metalloproteinase-1 (TIMP-1) in serum, quantified using ELISA. The ratio is calculated by dividing MMP-9 (ng/mL) by TIMP-1 (ng/mL). The endpoint is the change in MMP-9/TIMP-1 ratio from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Ankle-Brachial Index (ABI)
Time frame: Baseline and 12 weeks after intervention
The ankle-brachial index (ABI) is calculated as the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Measurements are obtained using a handheld Doppler device. ABI will be used as an indicator of peripheral vascular function and early risk of diabetic foot ulcer. The endpoint is the change in ABI from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- 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).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the published results will be made available in anonymized form. The data will be accessible upon reasonable request to the corresponding investigator after publication, in accordance with ethical approval and institutional policies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlucoBites (with Gynura procumbens) in people with Type 2 Diabetes Mellitus and Diabetic Neuropathy, run by Andina Setyawati at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andina Setyawati, Dr (+628121521639, andina@unhas.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (FBG) (time frame: Baseline and 12 weeks after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.