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

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.

Conditions

• Diabetes Mellitus (DM)
• Dyslipidemia
• Lipid Profile
• Functional Food
• Nutritional Intervention
• Cardiovascular Risk Factor

Interventions

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.

Sponsors & Collaborators

• Hasanuddin University

  lead OTHER

Principal Investigators

• ANDINA SETYAWATI, PhD, S.Kep., Ns., M.Kep. · Hasanuddin University, Faculty of Nursing

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-20

Primary Completion

2025-11-30

Completion

2025-12-31

Countries

• Indonesia

Study Locations