NCT04573218

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An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

September 28, 2020

Last Update Submit

April 5, 2022

Conditions

HyperlipidemiasHypercholesterolemia

Keywords

oil palm phenolicslipid profile

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Changes of Fasting lipid profile (total cholesterol)

    Baseline, day 30 and day 60 after supplementation

  • Changes of Fasting lipid profile (HDL cholesterol)

    Baseline,day 30 and day 60 after supplementation

  • Changes of Fasting lipid profile (Triglyceride)

    Baseline,day 30 and day 60 after supplementation

  • Changes of plasma inflammatory markers

    Baseline, day 30 and day 60 after supplementation

  • Changes of Plasma Antioxidant Levels

    Baseline, day 30 and day 60 after supplementation

  • +3 more secondary outcomes

Study Arms (2)

Group A

PLACEBO COMPARATOR

Glucose.

Drug: Placebo

Group B

ACTIVE COMPARATOR

250 mg Oil Palm Phenolics.

Dietary Supplement: 250 mg OPP

Interventions

PlaceboDRUG

The placebo contains glucose

Group A
250 mg OPPDIETARY_SUPPLEMENT

250 mg Oil Palm Phenolics

Group B

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Malaysia

Cheras, WP Kuala Lumpur, 56000, Malaysia

Location

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: 29844318BACKGROUND

  • Muhammad Ismail Tadj NB, Ibrahim NI, Tg Abu Bakar Sidik TMI, Zulfarina MS, Haji Mohd Saad Q, Leow SS, Fairus S, Naina Mohamed I. Safety and efficacy of oil palm phenolic supplementation in improving lipid profile among hyperlipidemic adults: a phase 2, randomized, double-blind, placebo-controlled clinical trial. Front Pharmacol. 2023 Jul 7;14:1190663. doi: 10.3389/fphar.2023.1190663. eCollection 2023.

    PMID: 37484009DERIVED

MeSH Terms

Conditions

HyperlipidemiasHypercholesterolemia

Interventions

4-(2-oxapentadeca-4-yne)phenylpropanoic acid

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Isa Naina Mohamed

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

October 18, 2021

Primary Completion

December 16, 2021

Study Completion

December 20, 2021

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)