The Effect of Golden Rice Cookies With Piper Crocatum Extract on Lipid Profile Control in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Change in total Cholesterol (mg/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Golden Rice cookies with Piper crocatum Extract (Dietary Supplement)
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.
干预措施: Placebo Cookies (Control) (Dietary Supplement)
结局指标
主要结局
Change in total Cholesterol (mg/dL)
时间窗: 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)
时间窗: 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)
时间窗: Baseline (Day 0) to Day 28
HDL cholesterol levels will be measured to determine improvement in protective lipid fractions.
Change in Triglycerides (mg/dL)
时间窗: Baseline (Day 0) to Day 28
Serum triglyceride levels will be measured to assess metabolic lipid response to the intervention.
次要结局
- Participant adherence Rate (%)(Baseline to Day 28)
- Incidence of Adverse Events (Number of Participants)(Baseline to Day 28)
研究者
Altje Suwardi Abram
S.Kep.,Ns
Hasanuddin University