Cardiovascular Risk Factor, Diabetes Mellitus (DM), Dyslipidemia, Functional Food, Lipid Profile, Nutritional Intervention
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTGolden 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_SUPPLEMENTPlacebo 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
Hasanuddin University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total Cholesterol (mg/dL) | 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. |
| Change in Low-Density Lipoprotein (LDL) Cholesterol (mg/dL) | Baseline (Day 0) to Day 28 | LDL cholesterol levels will be measured to evaluate changes following the 28-day intervention |
| Change in High-Density Lipoprotein (HDL) Cholesterol (mg/dL) | Baseline (Day 0) to Day 28 | HDL cholesterol levels will be measured to determine improvement in protective lipid fractions. |
| Change in Triglycerides (mg/dL) | Baseline (Day 0) to Day 28 | Serum triglyceride levels will be measured to assess metabolic lipid response to the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant adherence Rate (%) | 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. |
| Incidence of Adverse Events (Number of Participants) | 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. |
Countries
Indonesia
Contacts
STUDY_DIRECTORANDINA SETYAWATI, PhD, S.Kep., Ns., M.Kep.
Hasanuddin University, Faculty of Nursing
Outcome results
None listed