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

December 5, 2025 updated by: Altje Suwardi Abram, Hasanuddin University

The Effect of Golden Rice Cookies With Piper Crocatum Extract on Lipid Profile Control in Patients With Diabetes Mellitus

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Sulawesi
      • Donggala, Central Sulawesi, Indonesia, 94355
        • Tambu Primary Health Center (Puskesmas Tambu)
      • Palu, Central Sulawesi, Indonesia, 94111
        • RSUD Anutapura Palu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Golden Rice cookies With Piper Crocatum extract
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.
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.
Active Comparator: Active Comparator (Control)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total Cholesterol (mg/dL)
Time Frame: Baseline (Day 0) and after 28 days of intervention
Serum total cholesterol will be measured to assess the effect of Golden Rice cookies enriched with Piper crocatum extract on lipid control in patients with diabetes mellitus.
Baseline (Day 0) and after 28 days of intervention
Change in Low-Density Lipoprotein (LDL) Cholesterol (mg/dL)
Time Frame: Baseline (Day 0) to Day 28
LDL cholesterol levels will be measured to evaluate changes following the 28-day intervention
Baseline (Day 0) to Day 28
Change in High-Density Lipoprotein (HDL) Cholesterol (mg/dL)
Time Frame: Baseline (Day 0) to Day 28
HDL cholesterol levels will be measured to determine improvement in protective lipid fractions.
Baseline (Day 0) to Day 28
Change in Triglycerides (mg/dL)
Time Frame: Baseline (Day 0) to Day 28
Serum triglyceride levels will be measured to assess metabolic lipid response to the intervention.
Baseline (Day 0) to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant adherence Rate (%)
Time Frame: Baseline to Day 28
Daily adherence to the assigned cookie regimen will be monitored using participant self-report checklists and confirmed by the count of returned empty packaging during weekly follow-up visits. Adherence will be reported as the percentage of prescribed doses consumed over the 28-day intervention.
Baseline to Day 28
Incidence of Adverse Events (Number of Participants)
Time Frame: Baseline to Day 28
All adverse events and signs of intolerance (e.g., gastrointestinal symptoms, allergic reactions) potentially associated with the intervention will be documented throughout the study period. Events will be classified by type, severity, onset, duration, and relationship to the study product. Results will be reported as the number and percentage of participants experiencing at least one adverse event.
Baseline to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Investigators

  • Study Director: ANDINA SETYAWATI, PhD, S.Kep., Ns., M.Kep., Hasanuddin University, Faculty of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2025

Primary Completion (Actual)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UH2507094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data (IPD) for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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