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

Study acronym: GRPC-DM
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: details revised at 4 of 4 entries Show 4 more changesShow less
    • Trial completed
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 3 of 3 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
People with diabetes often experience abnormal blood fat levels, known as dyslipidemia, which increase the risk of heart disease and stroke. The aim of the study, researchers are exploring a natural and practical solution through a healthy snack in the form of cookies. These cookies are made from Golden Rice, which is rich in beta-carotene as a natural antioxidant, and Piper crocatum (red betel leaf) extract, which contains polyphenols and flavonoids that may help lower cholesterol, reduce inflammation, and protect blood vessels. In this study, patients with diabetes will consume the cookies for 28 days, and their blood fat levels will be measured before and after the intervention. The results will then be compared with those of a control group who receive the Golden rice cookies without piper crocatum extract. This research aims to show that Golden Rice with Piper crocatum extract cookies can reduce bad cholesterol and triglycerides, increase good cholesterol, and serve as a safe, affordable, and acceptable food option to support daily diabetes care. If successful, this approach may offer patients and families a simple way to help prevent complications and improve quality of life, alongside regular treatment and lifestyle changes.
Trial Details
NCT Number NCT07268781
Lead Sponsor Hasanuddin University
Conditions
(from sponsor)		 Diabetes Mellitus (DM), Dyslipidemia, Lipid Profile, Functional Food, Nutritional Intervention, Cardiovascular Risk Factor
Related terms Diabetes Mellitus, Dyslipidemias
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov