Trials / Active Not Recruiting
Active Not RecruitingNCT07268781
Impact of Golden Rice-Piper Crocatum Cookies on Lipid Control in Diabetes Mellitus Patients
The Effect of Golden Rice Cookies With Piper Crocatum Extract on Lipid Profile Control in Patients With Diabetes Mellitus
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- Hasanuddin University · Academic / Other
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This clinical trial evaluates the effect of Golden Rice cookies enriched with Piper crocatum (red betel leaf) extract on lipid profile control in patients with type 2 diabetes mellitus. The intervention is designed as a short-term, food-based strategy to complement existing diabetes management by integrating functional food into daily dietary practice. The rationale for this approach is based on evidence that beta-carotene from Golden Rice and polyphenols from Piper crocatum exert antioxidant, anti-inflammatory, and lipid-lowering activities. Combining these bioactive compounds in the form of cookies provides a culturally acceptable, affordable, and practical dietary intervention. The cookie format was selected due to its high acceptance, ease of distribution, and potential to improve adherence compared with capsule or extract preparations. This trial uses a controlled pre-post design to compare changes in lipid biomarkers between the intervention and control groups over 28 days. Key outcomes include serum levels of LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol. The study also explores potential synergistic effects on oxidative stress and inflammatory processes associated with dyslipidemia in diabetes. By translating the concept of functional food into a practical dietary item, this study aims to generate evidence for its role as an adjunctive therapy in diabetes care. Findings are expected to inform future dietary guidelines and nursing interventions, particularly in community-based settings where accessibility, patient adherence, and cost-effectiveness are critical considerations.
Conditions
- Diabetes Mellitus (DM)
- Dyslipidemia
- Lipid Profile
- Functional Food
- Nutritional Intervention
- Cardiovascular Risk Factor
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Golden Rice cookies with Piper crocatum Extract | Golden Rice cookies enriched with Piper crocatum extract, formulated as a functional food containing β-carotene and polyphenols with antioxidant, anti-inflammatory, and lipid-modulating properties. Participants will consume the cookies daily for 28 consecutive days in addition to their standard diabetes management. This intervention is designed to improve lipid metabolism and reduce dyslipidemia in patients with Diabetes Mellitus. |
| DIETARY_SUPPLEMENT | Placebo Cookies (Control) | Placebo cookies without Golden Rice or Piper crocatum extract, identical in appearance, taste, and packaging to the intervention cookies. Participants will consume placebo cookies daily for 28 consecutive days along with their standard diabetes management. This placebo is used to maintain participant blinding and provide a valid comparison. |
Timeline
- Start date
- 2025-10-20
- Primary completion
- 2025-11-30
- Completion
- 2025-12-31
- First posted
- 2025-12-08
- Last updated
- 2025-12-08
Locations
2 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT07268781. Inclusion in this directory is not an endorsement.