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临床试验/NCT04164446
NCT04164446Unknown1 期

Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Healthy Participants (Phase I Clinical Trial Study)

National University of Malaysia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
100
试验地点
1
主要终点
Incidence of Adverse Events following one-month supplementation (Safety and Tolerability)

研究概览

简要总结

Our previous study has found that oil palm phenolics (OPP) supplementation at 9 grams per day is safe for consumption. An interesting observation was reported where the consumption of OPP showed significantly lower total and LDL cholesterol compared to the control group. There is no clinical evidence as yet on the optimum dosage of OPP supplementation in improving fasting lipid profile. We hypothesize that in a clinical study, OPP supplemented participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability.

详细描述

During the palm oil milling process, a large amount of vegetation liquor is discarded into the aqueous waste stream. A novel process to recover phenolic compounds from the aqueous waste stream were developed and resulting in producing a filtrate known as oil palm phenolics (OPP), which contains a high amount of phenolic. It has been postulated that phenolic acids components found in the OPP have promising health benefits such as antioxidant, anti-inflammatory, neuroprotective and anti-tumour effects.

Hyperlipidemia, one of the risk factors for cardiovascular diseases (CVD), is defined as elevations of fasting total cholesterol or triglyceride concentration or both. Through our current 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, we hypothesize that supplementation of OPP may prevent or delay the development of CVD.

However, to understand the anti-hyperlipidemic effects of OPP in humans, we need to establish our knowledge of the physiological effects of this compound to normal human subjects. Under physiological condition, OPP may improve the antioxidant and anti-inflammatory status. These improvements may have a positive influence on plasma lipid profile since many scientific evidences demonstrate that antioxidant and anti-inflammatory effects may contribute protection against the incidence of CVD. Therefore, we proposed a clinical trial to evaluate the antioxidant and anti-inflammatory effects of OPP in eliciting the possible mechanism for lipid reduction.

This study will be started with the recruitment of 100 healthy volunteers where they will be supplemented with placebo/OPP capsules at different doses 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 us in understanding the therapeutic roles of OPP on humans under normal conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Normal Total Cholesterol level of less than 5.2 mmol/dL
  • Normal LDL Cholesterol level of less than 3.36 mmol/dL
  • Normal Triglyceride level of less than 1.69 mmol/dL

排除标准

  • Habitual alcohol consumption
  • Consuming antioxidant supplement
  • Pregnant/ breastfeeding
  • Medical history of cardiovascular disease, diabetes, dyslipidemia
  • Current use of antihypertensive or lipid-lowering medication

研究组 & 干预措施

Placebo

Placebo Comparator

Two capsules containing starch and glucose, once per day, 60 days duration

干预措施: Placebos (Drug)

Oil Palm Phenolics 250 mg

Active Comparator

One capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration

干预措施: Oil Palm Phenolics (Dietary Supplement)

Oil Palm Phenolics 1000 mg

Active Comparator

One capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration

干预措施: Oil Palm Phenolics (Dietary Supplement)

Oil Palm Phenolics 2000 mg

Active Comparator

Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration

干预措施: Oil Palm Phenolics (Dietary Supplement)

结局指标

主要结局

Incidence of Adverse Events following one-month supplementation (Safety and Tolerability)

时间窗: Day 30 after supplementation

This will be assessed via history, physical examination, kidney function test, liver function test and hematology profile from the plasma analysis on the fasting blood samples of each participant.

Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation

时间窗: Baseline, day 30, day 60

This will be assessed from the plasma analysis on the fasting blood samples of each participant

Incidence of Adverse Events following two-months supplementation (Safety and Tolerability)

时间窗: Day 60 after supplementation

This will be assessed via history, physical examination, kidney function test, liver function test and hematology profile from the plasma analysis on the fasting blood samples of each participant.

次要结局

  • Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation(Baseline, day 30 and day 60 after supplementation)
  • Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation.(Baseline, day 30 and day 60 after supplementation)
  • Changes from Baseline Concentrations of Plasma Inflammatory Markers using multiplex assays following one and two months supplementation(Baseline,day 30 and day 60 after supplementation)
  • Changes from Baseline Concentrations of Plasma Antioxidant Levels using ELISA method following one and two months supplementation(Baseline,day 30 and day 60 after supplementation)
  • Changes from Baseline Body Weight Measurement following one and two months supplementation(Baseline,day 30 and day 60 after supplementation)

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Isa Naina Mohamed

Associate Professor

National University of Malaysia

研究点 (1)

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