Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT07272993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Golden Rice-Piper Crocatum Cookies on Neuropathy Prevention in Diabetes
Sponsor:
Hasanuddin University
Organization:
Study Overview
Official Title:
The Effect of Golden Rice Cookies With Piper Crocatum on the Prevention of Diabetic Neuropathy in Patients With Diabetes Mellitus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRIP-DN
Brief 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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: