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

Andina Setyawati

Status: Not yet enrolling

Conditions: Diabetic Neuropathy; Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: GlucoBites (with Gynura procumbens); Dietary Supplement: Control Cookies (without Gynura procumbens)

Study type: Interventional

Funder types: Other

Identifiers

NCT07151833

02209/UN4.22/PT.01.03/2025 (Other Grant/Funding Number)

GlucoBites-DM2-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Control Cookies (without Gynura procumbens)

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control Cookies (without Gynura procumbens)

GlucoBites (with Gynura procumbens)

Experimental group

Description:

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

Treatment:

Dietary Supplement: GlucoBites (with Gynura procumbens)