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GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes

NCT07151833 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Andina Setyawati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-20
Primary Completion
2025-12-20
Completion
2026-01-20

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151833 on ClinicalTrials.gov