Effect of Golden Rice-Piper Crocatum Cookies on Neuropathy Prevention in Diabetes

Summary

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.

Conditions

• Diabetic Neuropathy
• Diabetes Mellitus (DM)
• Functional Food
• Nutritional Intervention
• Blood Glucose

Interventions

DIETARY_SUPPLEMENT

Golden Rice Cookies With Piper Crocatum

This intervention consists of a functional food product in the form of cookies made from golden rice flour, enriched with Piper crocatum (red betel leaf extract). The cookies are administered orally, once daily, over a 28-day period. What distinguishes this intervention from others is the combination of golden rice a biofortified grain rich in beta-carotene with Piper crocatum, a traditional Indonesian medicinal plant known for its antioxidant and anti-inflammatory properties. The formulation is designed to target diabetic neuropathy prevention by enhancing neuroprotective effects through dietary supplementation. The product is standardized in dosage, appearance, and packaging to support double-blind administration and ensure consistency across participants.

DIETARY_SUPPLEMENT

Golden Rice Cookies Without Piper Crocatum

This intervention consists of cookies made from golden rice flour without the addition of Piper crocatum (red betel leaf extract). The cookies are administered orally, once daily, for 28 consecutive days. Although lacking the herbal component, golden rice itself is a biofortified grain rich in beta-carotene, offering nutritional value. The control product is matched in appearance, taste, and packaging to the experimental cookies to maintain double-blind conditions. This intervention serves as an active comparator to isolate the effect of Piper crocatum in preventing diabetic neuropathy symptoms

Sponsors & Collaborators

• Hasanuddin University

  lead OTHER

Principal Investigators

• Dr. Andina Setyawati, S.Kep.,Ns.,M.Kep · Faculty of Nursing, Hasanuddin University

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-20

Primary Completion

2025-11-30

Completion

2025-12-31

Countries

• Indonesia

Study Locations