Supplementation of Oil Palm Phenolics to Healthy Participants (SPIRAL)

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Hypercholesterolemia; Hyperlipidemias
• Intervention / Treatment: Drug: Placebos; Dietary supplement: Oil Palm Phenolics

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nurul Izzah Ibrahim, PhD; Phone Number: +60132678770; Email: nurulizzah88@gmail.com
• Study Contact Backup: Name: Isa Naina Mohamed, MD, PhD; Phone Number: +60391459568; Email: isanaina@ppukm.edu.my

Study Locations

• Malaysia
  • WP Kuala Lumpur
    • Cheras, WP Kuala Lumpur, Malaysia, 56000
      • Recruiting
      • National University of Malaysia
      • Contact: Nurul Izzah Ibrahim, PhD; Phone Number: +60132678770; Email: nurulizzah88@gmail.com
      • Principal Investigator: Isa Naina Mohamed, MD, PhD
      • Sub-Investigator: Qodriah Mohd Saad, MBBS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Collaborators: Malaysia Palm Oil Board
• Investigators: Principal Investigator: Isa Naina Mohamed, MD, PhD, 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.
• Muhammad Ismail Tadj NB, Ibrahim N', Haji Mohd Saad Q, Tg Abu Bakar Sidik TMI, Leow SS, Fairus S, Naina Mohamed I. A Phase I, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Tolerance of Oil Palm Phenolics (OPP) in Healthy Volunteers. Front Pharmacol. 2022 Jun 20;13:893171. doi: 10.3389/fphar.2022.893171. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: HDL cholesterol; LDL cholesterol; lipid profile; oil palm phenolics
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: SPIRAL

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