Clinical trial NCT04573218: Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia
Official title: Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia (Phase 2 Clinical Trial Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemias
Hypercholesterolemia
Keywords: oil palm phenolics
lipid profile
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Malaysia Palm Oil Board
First posted: 2020-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Smoking
* 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

Primary outcomes:
measure: Changes of fasting plasma LDL cholesterol levels
timeFrame: Baseline, day 30, day 60 after supplementation
Secondary outcomes:
measure: Changes of Fasting lipid profile (total cholesterol)
timeFrame: Baseline, day 30 and day 60 after supplementation
measure: Changes of Fasting lipid profile (HDL cholesterol)
timeFrame: Baseline,day 30 and day 60 after supplementation
measure: Changes of Fasting lipid profile (Triglyceride)
timeFrame: Baseline,day 30 and day 60 after supplementation
measure: Changes of plasma inflammatory markers
timeFrame: Baseline, day 30 and day 60 after supplementation
measure: Changes of Plasma Antioxidant Levels
timeFrame: Baseline, day 30 and day 60 after supplementation
measure: Incidence of adverse events via evaluation of renal function test
timeFrame: Baseline, day 30 and day 60 after supplementation
measure: Incidence of adverse events via evaluation of liver function test
timeFrame: Baseline, day 30 and day 60 after supplementation
measure: Changes of Body weight measurement
timeFrame: Baseline, day 30 and day 60 after supplementation
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: National University of Malaysia
state: WP Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Isa Naina Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fairus S, Leow SS, Mohamed IN, Tan YA, Sundram K, Sambanthamurthi R. A phase I single-blind clinical trial to evaluate the safety of oil palm phenolics (OPP) supplementation in healthy volunteers. Sci Rep. 2018 May 29;8(1):8217. doi: 10.1038/s41598-018-26384-7.