Supplementation of Oil Palm Phenolics to Healthy Participants

NCT04164446 | Unknown Phase 1

• 1 other identifier: SPIRAL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Hyperlipidemias; Hypercholesterolemia

Keywords

oil palm phenolics; lipid profile; LDL cholesterol; HDL cholesterol

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Changes from Baseline Fasting Lipid Profile (total and HDL cholesterol, triacylglycerides) following one and two months supplementation

  Baseline, day 30 and day 60 after supplementation

• Changes from Baseline Fasting LDL and HDL Cholesterol Subfractions following one and two months supplementation.

  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

  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

  Baseline,day 30 and day 60 after supplementation

• Changes from Baseline Body Weight Measurement following one and two months supplementation

  Baseline,day 30 and day 60 after supplementation

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Two capsules containing starch and glucose, once per day, 60 days duration

Drug: Placebos

Oil Palm Phenolics 250 mg

ACTIVE COMPARATOR

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

Oil Palm Phenolics 1000 mg

ACTIVE COMPARATOR

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

Oil Palm Phenolics 2000 mg

ACTIVE COMPARATOR

Two capsules, 1000 mg active compound (OPP) each, once per day, 60 days duration

Dietary Supplement: Oil Palm Phenolics

Interventions

Placebos DRUG

The placebo that will be used contains starch and glucose.

Also known as: Placebo

Placebo

Oil Palm Phenolics DIETARY_SUPPLEMENT

One capsule contains 250 mg OPP or 1 g OPP

Oil Palm Phenolics 1000 mg; Oil Palm Phenolics 2000 mg; Oil Palm Phenolics 250 mg

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University of Malaysia: lead
• Malaysia Palm Oil Board: collaborator

Study Sites (1)

National University of Malaysia

Cheras, WP Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (2)

• 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.

  PMID: 29844318 RESULT

• 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.

  PMID: 35795564 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hyperlipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Isa Naina Mohamed, MD, PhD

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurul Izzah Ibrahim, PhD

CONTACT

+60132678770; nurulizzah88@gmail.com

Isa Naina Mohamed, MD, PhD

CONTACT

+60391459568; isanaina@ppukm.edu.my

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 15, 2019
• Study Start: December 16, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)