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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Golden Rice-Piper Crocatum Cookies on Lipid Control in Diabetes Mellitus Patients

NCT07268781

Diabetes Mellitus (DM) Dyslipidemia Lipid Profile +3 more

ACTIVE_NOT_RECRUITING NA

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

NCT07151833

Type 2 Diabetes Mellitus Diabetic Neuropathy

NOT_YET_RECRUITING NA

Golden Rice Cookies With Piper Crocatum for Blood Glucose Control and Quality of Life in People Living With HIV With Hyperglycemia

NCT07187648

HIV Infections Nutritional Intervention Blood Glucose +1 more

NOT_YET_RECRUITING NA

Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study

NCT05272839

Type II Diabetes

UNKNOWN NA

MMP-9/NGAL Modulation by Piper Crocatum in Early Diabetic Nephropathy

NCT06676124

Early Renal Dysfunction in Diabetes Diabetic Nephropathy Inflammation and Oxidative Stress in Diabetic Patients

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study is designed as a randomized controlled trial using a pre-test and post-test design with a control group. Eligible participants are patients diagnosed with diabetes mellitus who present with symptoms of diabetic neuropathy. Participants will be randomly assigned into two groups: the intervention group receiving golden rice cookies enriched with Piper crocatum extract, and the control group receiving golden rice cookies without Piper crocatum.

The intervention will be administered for 28 consecutive days, with both groups monitored under similar conditions. Assessments will be conducted at baseline (pre-test) and after the intervention period (post-test). The primary outcome measure is the change in Neuropathy Symptom Score (NSS), while secondary outcomes include blood glucose monitoring and simple neuropathy screening tests (monofilament test).

This interventional model allows for direct comparison between the functional food intervention and the control to determine the ef

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

In this study, participants will not be informed whether they are receiving golden rice cookies with Piper crocatum extract or golden rice cookies without Piper crocatum. The cookies are prepared to be similar in appearance, texture, and packaging to minimize bias. Outcome assessors who evaluate neuropathy symptoms using the Neuropathy Symptom Score (NSS) and perform the monofilament test will also be masked to group assignment.

This masking strategy is intended to reduce reporting bias from participants and measurement bias from outcome assessors, ensuring the reliability of the study results.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Golden Rice Cookies Enriched with Piper Crocatum

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

Group Type EXPERIMENTAL

Golden Rice Cookies With Piper Crocatum

Intervention Type DIETARY_SUPPLEMENT

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.

Golden Rice Cookies Without Piper Crocatum

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.

Group Type ACTIVE_COMPARATOR

Golden Rice Cookies Without Piper Crocatum

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No