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Supplementation of Oil Palm Phenolics to Healthy Participants (SPIRAL)

2019年12月20日 更新者:Isa Naina Mohamed、National University of Malaysia

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (预期的)

100

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • WP Kuala Lumpur
      • Cheras、WP Kuala Lumpur、马来西亚、56000
        • 招聘中
        • National University of Malaysia
        • 接触:
        • 首席研究员:
          • Isa Naina Mohamed, MD, PhD
        • 副研究员:
          • Qodriah Mohd Saad, MBBS, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy
  • 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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:Placebo
Two capsules containing starch and glucose, once per day, 60 days duration
The placebo that will be used contains starch and glucose.
其他名称:
  • 安慰剂
有源比较器:Oil Palm Phenolics 250 mg
One capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration
One capsule contains 250 mg OPP or 1 g OPP
有源比较器:Oil Palm Phenolics 1000 mg
One capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration
One capsule contains 250 mg OPP or 1 g OPP
有源比较器:Oil Palm Phenolics 2000 mg
Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration
One capsule contains 250 mg OPP or 1 g OPP

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation
大体时间:Baseline, day 30, day 60
This will be assessed from the plasma analysis on the fasting blood samples of each participant
Baseline, day 30, day 60
Incidence of Adverse Events following one-month supplementation (Safety and Tolerability)
大体时间: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.
Day 30 after supplementation
Incidence of Adverse Events following two-months supplementation (Safety and Tolerability)
大体时间: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.
Day 60 after supplementation

次要结果测量

结果测量
措施说明
大体时间
Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation
大体时间:Baseline, day 30 and day 60 after supplementation
This will be assessed from the plasma analysis on the fasting blood samples of each participant.
Baseline, day 30 and day 60 after supplementation
Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation.
大体时间:Baseline, day 30 and day 60 after supplementation
This will be assessed from the plasma analysis on the fasting blood samples of each participant.
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
大体时间:Baseline,day 30 and day 60 after supplementation
Inflammatory markers such as Interleukin-6, Interleukin-1beta, Tumour Necrosis Factor-alpha, Interleukin-10 and interferon-Gamma will be assessed from the plasma analysis on the fasting blood samples of each participant.
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
大体时间:Baseline,day 30 and day 60 after supplementation
Antioxidant levels such as Malonaldehyde and Superoxide dismutase will be assessed from the plasma analysis on the fasting blood samples of each participant.
Baseline,day 30 and day 60 after supplementation
Changes from Baseline Body Weight Measurement following one and two months supplementation
大体时间:Baseline,day 30 and day 60 after supplementation
This will be assessed by measuring the weight of each participant.
Baseline,day 30 and day 60 after supplementation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Isa Naina Mohamed, MD, PhD、National University of Malaysia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月16日

初级完成 (预期的)

2020年4月1日

研究完成 (预期的)

2020年4月1日

研究注册日期

首次提交

2019年11月10日

首先提交符合 QC 标准的

2019年11月14日

首次发布 (实际的)

2019年11月15日

研究记录更新

最后更新发布 (实际的)

2019年12月23日

上次提交的符合 QC 标准的更新

2019年12月20日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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