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

NCT07268781 | Active Not Recruiting

• 1 other identifier: UH2507094
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change in total Cholesterol (mg/dL)

  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)

  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)

  HDL cholesterol levels will be measured to determine improvement in protective lipid fractions.

  Baseline (Day 0) to Day 28

• Change in Triglycerides (mg/dL)

  Serum triglyceride levels will be measured to assess metabolic lipid response to the intervention.

  Baseline (Day 0) to Day 28

Secondary Outcomes (2)

• Participant adherence Rate (%)

  Baseline to Day 28

• Incidence of Adverse Events (Number of Participants)

  Baseline to Day 28

Study Arms (2)

Golden Rice cookies With Piper Crocatum extract

EXPERIMENTAL

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

Active Comparator (Control)

ACTIVE COMPARATOR

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)

Interventions

Golden Rice cookies with Piper crocatum Extract DIETARY_SUPPLEMENT

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.

Golden Rice cookies With Piper Crocatum extract

Placebo Cookies (Control) DIETARY_SUPPLEMENT

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.

Active Comparator (Control)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (2)

Tambu Primary Health Center (Puskesmas Tambu)

Donggala, Central Sulawesi, 94355, Indonesia

Location

RSUD Anutapura Palu

Palu, Central Sulawesi, 94111, Indonesia

Location

Related Publications (3)

• Setyawati A, Saleh A, Tahir T, Yusuf S, Syahrul S, Aminuddin A, Raihan M, Jafar N, Hamzah H, Arfian N. Matrix Metalloproteinase-9 Testing of Golden Rice Cookies With Piper Crocatum Active Extract for Preventing Foot Ulcers in Patients With Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 29;13:e49940. doi: 10.2196/49940.

  PMID: 38422498 BACKGROUND

• https://jppres.com/jppres/pdf/vol13/jppres25.2499_13.6.1847.pdf

  RESULT

• Setyawati A, Wahyuningsih MSH, Nugrahaningsih DAA, Effendy C, Fneish F, Fortwengel G. Piper crocatum Ruiz & Pav. ameliorates wound healing through p53, E-cadherin and SOD1 pathways on wounded hyperglycemia fibroblasts. Saudi J Biol Sci. 2021 Dec;28(12):7257-7268. doi: 10.1016/j.sjbs.2021.08.039. Epub 2021 Aug 19.

  PMID: 34867030 RESULT

Related Links

• Official website of the Faculty of Nursing, Universitas Hasanuddin.
• Universitas Hasanuddin official website.

MeSH Terms

Conditions

Diabetes Mellitus; Dyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• ANDINA SETYAWATI, PhD, S.Kep., Ns., M.Kep.

  Hasanuddin University, Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed about whether they are in the intervention or control group, since both groups will receive packaged cookies that appear identical. Investigators and care providers will know the allocation in order to ensure proper delivery of the intervention, but outcome assessors and laboratory personnel measuring lipid profiles will remain blinded to minimize bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: S.Kep.,Ns

Model Details: This study is an interventional clinical trial with a parallel-group design to evaluate the effect of Golden Rice cookies enriched with Piper crocatum extract on lipid profile control in patients with Type 2 Diabetes Mellitus. Participants will be divided into two groups: the intervention group, which will receive Golden Rice cookies containing Piper crocatum extract for 28 consecutive days, and the control group, which will receive standard care (placebo) without the functional food intervention. The study follows a pre-test and post-test control group design, where lipid profile parameters including total cholesterol, LDL, HDL, and triglycerides will be assessed at baseline and after the 28-day intervention period. The allocation is randomized, while masking is not applied due to the nature of the dietary intervention. The primary purpose of this study is treatment, aiming to improve lipid metabolism, reduce dyslipidemia, and prevent cardiovascular complications in patients with

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 8, 2025
• Study Start: October 20, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)