Effect of Golden Rice-Piper Crocatum Cookies on Neuropathy Prevention in Diabetes (GRIP-DN)

Hasanuddin University

Status: Active, not recruiting

Conditions: Diabetic Neuropathy; Diabetes Mellitus (DM); Blood Glucose; Functional Food; Nutritional Intervention

Treatments: Dietary Supplement: Golden Rice Cookies With Piper Crocatum; Dietary Supplement: Golden Rice Cookies Without Piper Crocatum

Study type: Interventional

Funder types: Other

Identifiers

NCT07272993

UH2508103

Details and patient eligibility

About

Diabetes mellitus is a chronic disease that can cause many complications, one of the most common being diabetic neuropathy. This condition occurs due to long-term high blood sugar levels that damage the nerves. Symptoms include tingling, burning, pain, and loss of sensation in the feet. If not prevented, neuropathy can progress to diabetic foot ulcers and even lead to amputation.

This study aims to evaluate whether Golden Rice Cookies enriched with Red Betel Leaf (Piper crocatum) can help prevent diabetic neuropathy in patients with diabetes. Golden rice is a type of rice that contains beta-carotene (provitamin A) and high fiber, which help maintain stable blood sugar levels and reduce oxidative stress. Meanwhile, red betel leaf contains flavonoids, polyphenols, and alkaloids with antioxidant, anti-inflammatory, and hypoglycemic properties that may protect nerves from damage.

Cookies were chosen as the intervention form because they are practical, easy to consume, and widely accepted by patients. In this study, patients will be divided into two groups: an intervention group receiving golden rice cookies with red betel leaf extract, and a control group receiving golden rice cookies without the extract. Changes in neuropathy symptoms will be assessed using the Neuropathy Symptom Score (NSS) before and after the intervention.

The expected outcome of this research is to provide scientific evidence that the combination of golden rice and red betel leaf in the form of cookies can serve as an effective, safe, and acceptable functional food to help prevent diabetic neuropathy. This nutritional intervention may support comprehensive diabetes management and improve patients' quality of life.

Full description

Diabetes mellitus is a chronic metabolic disease with a steadily increasing prevalence worldwide. One of its most common and burdensome complications is diabetic neuropathy, which affects up to 50% of patients with type 2 diabetes. This condition is characterized by pain, tingling, or loss of sensation, particularly in the feet, and is a major risk factor for diabetic foot ulcers and amputations. Current management strategies mainly focus on strict glycemic control and the treatment of neuropathic pain, while preventive nutritional approaches remain limited.

With the growing interest in functional foods, new opportunities have emerged to support diabetes care. Golden rice, genetically enriched with beta-carotene (provitamin A), provides antioxidant and anti-inflammatory benefits along with dietary fiber that helps stabilize blood glucose levels. Red betel leaf (Piper crocatum), traditionally used in herbal medicine, contains flavonoids, polyphenols, and alkaloids with antioxidant, anti-inflammatory, and hypoglycemic properties that may protect nerves from damage caused by chronic hyperglycemia. The combination of these two functional ingredients offers promising neuroprotective potential for the prevention of diabetic neuropathy.

This study is designed as a randomized controlled trial using cookies made from golden rice enriched with Piper crocatum as the intervention. Cookies are chosen as the delivery form because they are practical, well-accepted by patients, and easy to consume regularly compared with supplements or herbal preparations. Participants will be divided into two groups: an intervention group receiving golden rice cookies with Piper crocatum extract, and a control group receiving golden rice cookies without the extract.

Throughout the 28-day intervention period, changes in neuropathy symptoms will be evaluated using the Neuropathy Symptom Score (NSS) before and after consumption. The study aims to determine whether the addition of Piper crocatum provides added benefits in preventing or reducing neuropathy symptoms compared with golden rice cookies alone.

This research is expected to provide scientific evidence on the role of combining golden rice and Piper crocatum in cookie form as an innovative functional food for the prevention of diabetic neuropathy. Such a nutritional intervention may offer an effective, safe, affordable, and acceptable strategy to support comprehensive diabetes management and improve patients' quality of life.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged between 18 and 59 years
• Diagnosed with diabetes mellitus based on medical records
• Able to read and communicate effectively
• Willing to participate in the study, sign the informed consent form, and commit to consuming the cookies according to the prescribed dosage

Exclusion criteria

• Pregnant or breastfeeding women
• Patients with a history of allergy to any component of the intervention, including golden rice or Piper crocatum
• Patients with active diabetic foot ulcers

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Golden Rice Cookies Enriched with Piper Crocatum

Experimental group

Description:

Participants assigned to this arm will receive cookies formulated with golden rice flour and enriched with Piper crocatum (red betel leaf extract). The cookies are consumed daily over a 28-day period. This intervention is designed to evaluate the potential neuroprotective effects of Piper crocatum in preventing or reducing symptoms of diabetic neuropathy among patients with type 2 diabetes mellitus. The formulation aims to leverage the antioxidant and anti-inflammatory properties of Piper crocatum in combination with the nutritional benefits of golden rice

Treatment:

Dietary Supplement: Golden Rice Cookies With Piper Crocatum

Golden Rice Cookies Without Piper Crocatum

Active Comparator group

Description:

Participants in this arm will receive cookies made exclusively from golden rice flour, without the addition of Piper crocatum. These cookies are also consumed daily for 28 days. This control intervention is intended to isolate the effect of Piper crocatum by comparing outcomes with the experimental group. Both cookie types are matched in appearance, taste, and packaging to maintain blinding integrity.

Treatment:

Dietary Supplement: Golden Rice Cookies Without Piper Crocatum