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

NCT ID: NCT04573218

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2021-12-20

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An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate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

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.

Conditions

Hyperlipidemias; Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

Glucose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo contains glucose

Group B

250 mg Oil Palm Phenolics.

Group Type: ACTIVE_COMPARATOR

250 mg OPP

Intervention Type: DIETARY_SUPPLEMENT

250 mg Oil Palm Phenolics

Interventions

Placebo

The placebo contains glucose

Intervention Type: DRUG

250 mg OPP

250 mg Oil Palm Phenolics

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role: collaborator

Isa Naina Mohamed

OTHER

Sponsor Role: lead

Responsible Party

Isa Naina Mohamed

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isa Naina Mohamed

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Locations

National University of Malaysia

Cheras, WP Kuala Lumpur, Malaysia

Countries

Malaysia

References

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: BACKGROUND

PMID: 29844318 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37484009 (View on PubMed)

Other Identifiers

SAPPHIRE

Identifier Type: -

Identifier Source: org_study_id