Impact of Golden Rice-Piper Crocatum Cookies on Lipid Control in Diabetes Mellitus Patients (GRPC-DM)

Hasanuddin University

Status: Active, not recruiting

Conditions: Lipid Profile; Diabetes Mellitus (DM); Functional Food; Nutritional Intervention; Dyslipidemia; Cardiovascular Risk Factor

Treatments: Dietary Supplement: Placebo Cookies (Control); Dietary Supplement: Golden Rice cookies with Piper crocatum Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07268781

UH2507094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18-59 years.
• Patients diagnosed with Type 2 Diabetes Mellitus based on medical records at Tambu Primary Health Center.
• Able to read and communicate effectively with healthcare staff.
• Permanent resident in the Tambu area.
• Willing to participate in the intervention and follow-up evaluations for the duration of the study.

Exclusion criteria

• Pregnant or breastfeeding women, or those currently undergoing a pregnancy program.
• Patients with mental health disorders.
• Patients with severe comorbidities affecting lipid metabolism, such as chronic kidney disease (CKD), hepatitis, congestive heart failure, stroke, or acute coronary syndrome within the past 3 months.
• Patients who have consumed herbal supplements or high-dose antioxidants within the last month.
• Patients with severe gastrointestinal disorders, such as chronic diarrhea.
• Patients with a history of allergy to any ingredients used in the study intervention.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Golden Rice cookies With Piper Crocatum extract

Experimental group

Description:

Participants will receive Golden Rice cookies enriched with Piper crocatum extract as a daily dietary supplement for 28 consecutive days. The cookies are formulated as a functional food, providing β-carotene from Golden Rice and polyphenols from Piper crocatum, which have antioxidant, anti-inflammatory, and lipid-modulating properties. The intervention aims to improve lipid metabolism by reducing total cholesterol, LDL, and triglycerides while increasing HDL levels in patients with Diabetes Mellitus.

Treatment:

Dietary Supplement: Golden Rice cookies with Piper crocatum Extract

Active Comparator (Control)

Active Comparator group

Description:

Participants will receive Golden Rice cookies without Piper crocatum extract, identical in appearance and packaging to the intervention cookies, for 28 consecutive days. This control is designed to maintain participant blinding and to serve as a comparison for evaluating the specific effects of Piper crocatum extract on lipid profile outcomes.

Treatment:

Dietary Supplement: Placebo Cookies (Control)