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Supplementation of Oil Palm Phenolics to Healthy Participants

NCT ID: NCT04164446

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Hyperlipidemias Hypercholesterolemia

Keywords

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oil palm phenolics lipid profile LDL cholesterol HDL cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

The placebo that will be used contains starch and glucose.

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

Group Type ACTIVE_COMPARATOR

Oil Palm Phenolics

Intervention Type DIETARY_SUPPLEMENT

One capsule contains 250 mg OPP or 1 g OPP

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

Group Type ACTIVE_COMPARATOR

Oil Palm Phenolics

Intervention Type DIETARY_SUPPLEMENT

One capsule contains 250 mg OPP or 1 g OPP

Oil Palm Phenolics 2000 mg

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

Group Type ACTIVE_COMPARATOR

Oil Palm Phenolics

Intervention Type DIETARY_SUPPLEMENT

One capsule contains 250 mg OPP or 1 g OPP

Interventions

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Placebos

The placebo that will be used contains starch and glucose.

Intervention Type DRUG

Oil Palm Phenolics

One capsule contains 250 mg OPP or 1 g OPP

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role collaborator

National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Isa Naina Mohamed

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isa Naina Mohamed, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Locations

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National University of Malaysia

Cheras, WP Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Nurul Izzah Ibrahim, PhD

Role: CONTACT

Phone: +60132678770

Email: [email protected]

Isa Naina Mohamed, MD, PhD

Role: CONTACT

Phone: +60391459568

Email: [email protected]

Facility Contacts

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Nurul Izzah Ibrahim, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 29844318 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35795564 (View on PubMed)

Other Identifiers

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SPIRAL

Identifier Type: -

Identifier Source: org_study_id