Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia

Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia (Phase 2 Clinical Trial Study)

An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Hyperlipidemias
• Intervention / Treatment: Drug: Placebo; Dietary supplement: 250 mg OPP

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Malaysia
  • WP Kuala Lumpur
    • Cheras, WP Kuala Lumpur, Malaysia, 56000
      • National University of Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; Glucose.	Drug: Placebo; The placebo contains glucose
Active Comparator: Group B; 250 mg Oil Palm Phenolics.	Dietary supplement: 250 mg OPP; 250 mg Oil Palm Phenolics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of fasting plasma LDL cholesterol levels	This will be assessed from the Fasting Plasma LDL Cholesterol level of each participant following one month and two months supplementation.	Baseline, day 30, day 60 after supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Fasting lipid profile (total cholesterol)	This will be assessed from the Fasting Plasma Total Cholesterol level of each participant following one month and two months supplementation	Baseline, day 30 and day 60 after supplementation
Changes of Fasting lipid profile (HDL cholesterol)	This will be assessed from the Fasting Plasma HDL Cholesterol level of each participant following one month and two months supplementation	Baseline,day 30 and day 60 after supplementation
Changes of Fasting lipid profile (Triglyceride)	This will be assessed from the Fasting Plasma Triglyceride level of each participant following one month and two months supplementation	Baseline,day 30 and day 60 after supplementation
Changes of plasma inflammatory markers	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 following one and two months of supplementation. The measurement of the plasma inflammatory markers will be performed by Multiplex assay method.	Baseline, day 30 and day 60 after supplementation
Changes of Plasma Antioxidant Levels	Antioxidant levels such as Malonaldehyde and Superoxide dismutase will be assessed from the plasma analysis on the fasting blood samples of each participant following one and two months of supplementation. The measurement of the antioxidant levels will be performed by Using ELISA Method.	Baseline, day 30 and day 60 after supplementation
Incidence of adverse events via evaluation of renal function test	This will be assessed by Kidney Function test from the fasting plasma analysis of each participant following one month and two months supplementation	Baseline, day 30 and day 60 after supplementation
Incidence of adverse events via evaluation of liver function test	This will be assessed by Liver Function Test from the fasting plasma analysis of each participants following one-month and two-months supplementation	Baseline, day 30 and day 60 after supplementation
Changes of Body weight measurement	This will be assessed by measuring the weight of each participant. Any drastic change in body weight will indicate non-compliance.	Baseline, day 30 and day 60 after supplementation

Collaborators and Investigators

• Sponsor: Isa Naina Mohamed
• Collaborators: Malaysia Palm Oil Board
• Investigators: Principal Investigator: Isa Naina Mohamed, National University of Malaysia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): December 16, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: lipid profile; oil palm phenolics
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: SAPPHIRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No