Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia (Phase 2 Clinical Trial Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes of fasting plasma LDL cholesterol levels
研究概览
简要总结
An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate the ability to lower total and LDL cholesterol. There is no clinical evidence as yet on that optimum dosage of OPP supplementation in improving fasting lipid profile in minor hyperlipidemia subjects. The investigators hypothesize that in a clinical study, OPP supplemented to the minor hyperlipidemic participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability. OPP may have the potential to be positioned as natural health supplement in improving lipid profile.
详细描述
Oil palm phenolics (OPP) is a product filtrated from vegetation liquor of an aqueous waste stream following palm oil milling process. A novel process to recover OPP that contains a high amount of phenolic from the waste has been explored tremendously. Due to the high phenolic content, OPP has been postulated in possessing various medicinal properties such as antioxidant, anti-inflammatory, neuroprotective and anti-tumour effects.
Hyperlipidemia is a well-known risk factor for cardiovascular diseases (CVD). It can be defined as elevations of fasting total cholesterol or triglyceride concentration or both. According to a previous research, OPP supplementation to hamster animal model has shown positive effects in the reduction of total cholesterol and triglycerides as well as improvement of high-density lipoprotein cholesterol (HDL-C). In a previous study using the rabbit animal model, OPP has shown a protective effect against atherosclerosis, a condition whereby fat and cholesterol plaques are deposited inside the arteries. Based on the current evidence from the preliminary studies on OPP, the investigators hypothesize that supplementation of OPP may prevent or delay the development of CVD.
In the investigator's previous clinical trial phase I, an optimum dosage of OPP has been obtained. Therefore, the investigators proposed a phase II clinical trial to evaluate the ability of OPP to reduce the total and LDL cholesterol in minor hyperlipidemic participants.
This study will be initiated with the recruitment of 50 volunteers with minor hyperlipidemic condition. In this study, the participants will be supplemented with placebo/OPP capsules for 60 days. Participants will be required to take the placebo/OPP capsules in front of the study staff to ensure compliance. Blood samples will be withdrawn at baseline, day 30 and day 60, and will be analyzed for lipid profile, antioxidant and anti-inflammatory status. Data from this study would hopefully assist the investigator in understanding the therapeutic roles of OPP in humans under minor hyperlipidemic conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elevated Fasting Total cholesterol level of more than 5.2 mmol/L
- •Elevated Fasting LDL cholesterol of more than 3.36 mmol/L*
- •Elevated Fasting Triglycerides of more than 1.69 mmol/L*
- •Willing to remain staying in Klang Valley area in the case of Movement Control Order implementation.
排除标准
- •Elevated Total cholesterol level of more than 6.2 mmol/L
- •Elevated LDL cholesterol of more than 4.9 mmol/L
- •Elevated Triglycerides of more than 5.6 mmol/L
- •Habitual alcohol consumption
- •Consuming antioxidant supplement
- •Pregnant/ breastfeeding
- •Medical history of cardiovascular disease, diabetes, dyslipidemia, familial hyperlipidemia, hypothyroidism, kidney disease and endocrine disease.
- •Current use of lipid-lowering medication
研究组 & 干预措施
Group A
Glucose.
干预措施: Placebo (Drug)
Group B
250 mg Oil Palm Phenolics.
干预措施: 250 mg OPP (Dietary Supplement)
结局指标
主要结局
Changes of fasting plasma LDL cholesterol levels
时间窗: Baseline, day 30, day 60 after supplementation
This will be assessed from the Fasting Plasma LDL Cholesterol level of each participant following one month and two months supplementation.
次要结局
- Changes of plasma inflammatory markers(Baseline, day 30 and day 60 after supplementation)
- Incidence of adverse events via evaluation of liver function test(Baseline, day 30 and day 60 after supplementation)
- Changes of Body weight measurement(Baseline, day 30 and day 60 after supplementation)
- Changes of Fasting lipid profile (total cholesterol)(Baseline, day 30 and day 60 after supplementation)
- Changes of Fasting lipid profile (HDL cholesterol)(Baseline,day 30 and day 60 after supplementation)
- Changes of Fasting lipid profile (Triglyceride)(Baseline,day 30 and day 60 after supplementation)
- Changes of Plasma Antioxidant Levels(Baseline, day 30 and day 60 after supplementation)
- Incidence of adverse events via evaluation of renal function test(Baseline, day 30 and day 60 after supplementation)
研究者
Isa Naina Mohamed
Associate Professor
National University of Malaysia