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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

August 22, 2025

Last Update Submit

September 2, 2025

Conditions

Type 2 Diabetes MellitusDiabetic Neuropathy

Keywords

Diabetes Mellitus Type 2Functional FoodGynura procumbensGlycemic ControlInsulin ResistanceDiabetic Foot Ulcer Prevention

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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).

    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).

    Baseline and 12 weeks after intervention

Study Arms (2)

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.

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.

Dietary Supplement: GlucoBites (with Gynura procumbens)

Interventions

GlucoBites (with Gynura procumbens)DIETARY_SUPPLEMENT

Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.

Also known as: Functional Cookies with Gynura procumbens
GlucoBites (with Gynura procumbens)
Control Cookies (without Gynura procumbens)DIETARY_SUPPLEMENT

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.

Also known as: Placebo cookies
Control Cookies (without Gynura procumbens)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Centre of Campagaloe

Bantaeng, South Sulawesi, 92411, Indonesia

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic NeuropathiesInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsHyperinsulinism

Central Study Contacts

Andina Setyawati, Dr

CONTACT

+628121521639andina@unhas.ac.id

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants in both arms receive visually identical cookies. The experimental cookies contain Gynura procumbens extract, while the control cookies do not. Packaging, appearance, weight, and flavor are matched. Randomization codes are held by an independent pharmacist/allocator; care providers and outcomes assessors are blinded to group assignment. Unblinding will occur only after database lock or for safety reasons.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2025

First Posted

September 3, 2025

Study Start

September 20, 2025

Primary Completion

December 20, 2025

Study Completion

January 20, 2026

Last Updated

September 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD and supporting documents (study protocol, statistical analysis plan, and informed consent form) will be available within 6 months after publication of the main results and will remain available for 5 years
Access Criteria
De-identified individual participant data (IPD) and supporting documents will be available to qualified researchers for academic and scientific purposes. Access will be granted upon reasonable request to the sponsor or principal investigator, subject to approval of a data use agreement

Locations

ID(1)