Supplementation of Oil Palm Phenolics to Healthy Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiovascular Diseases, Hyperlipidemias, Hypercholesterolemia

Intervention / Treatment
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* Drug: Placebos
* Dietary Supplement: Oil Palm Phenolics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Two capsules containing starch and glucose, once per day, 60 days duration | Drug: Placebos<br>* The placebo that will be used contains starch and glucose.<br>* Other names: Placebo;|
| Active Comparator: Oil Palm Phenolics 250 mg<br>One capsule 250 mg active compound (OPP) and one capsule containing starch and glucose, once per day, 60 days duration | Dietary Supplement: Oil Palm Phenolics<br>* One capsule contains 250 mg OPP or 1 g OPP<br>|
| Active Comparator: Oil Palm Phenolics 1000 mg<br>One capsule containing 1000 mg active compound (OPP) and one capsule starch and glucose, once per day, 60 days duration | Dietary Supplement: Oil Palm Phenolics<br>* One capsule contains 250 mg OPP or 1 g OPP<br>|
| Active Comparator: Oil Palm Phenolics 2000 mg<br>Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration | Dietary Supplement: Oil Palm Phenolics<br>* One capsule contains 250 mg OPP or 1 g OPP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Fasting Plasma LDL Cholesterol level following one and two months supplementation | 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) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months 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. | 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 | 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 | 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 | This will be assessed by measuring the weight of each participant. | Baseline,day 30 and day 60 after supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oil palm phenolics, lipid profile, LDL cholesterol, HDL cholesterol