← Back to all trials
Completed
NCT07272993
Effect of Golden Rice-Piper Crocatum Cookies on Neuropathy Prevention in Diabetes
Conditions: Diabetic Neuropathy, Diabetes Mellitus (DM), Functional Food, Nutritional Intervention, Blood Glucose
Sex: All
Ages: 18 Years – 59 Years
Healthy volunteers: No
Phase: NA
Enrollment: 102
Sponsor: Hasanuddin University
Location: UPTD Puskesmas Lompeta Singgani Tambu Donggala Central Sulawesi
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07272993). StuddyBuddy aggregates publicly available trial information.