Skip to main content
OpenTrials
Completed

NCT Number: NCT04573218

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

An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate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

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National University of Malaysia

Cheras, WP Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

The placebo contains glucose

250 mg OPP

Dietary Supplement

250 mg Oil Palm Phenolics

Primary outcomes

  1. Changes of fasting plasma LDL cholesterol levels

    Time frame: Baseline, day 30, day 60 after supplementation

    This will be assessed from the Fasting Plasma LDL Cholesterol level of each participant following one month and two months supplementation.

Secondary outcomes

  1. Changes of Fasting lipid profile (total cholesterol)

    Time frame: Baseline, day 30 and day 60 after supplementation

    This will be assessed from the Fasting Plasma Total Cholesterol level of each participant following one month and two months supplementation

  2. Changes of Fasting lipid profile (HDL cholesterol)

    Time frame: Baseline,day 30 and day 60 after supplementation

    This will be assessed from the Fasting Plasma HDL Cholesterol level of each participant following one month and two months supplementation

  3. Changes of Fasting lipid profile (Triglyceride)

    Time frame: Baseline,day 30 and day 60 after supplementation

    This will be assessed from the Fasting Plasma Triglyceride level of each participant following one month and two months supplementation

  4. Changes of plasma inflammatory markers

    Time frame: Baseline, day 30 and day 60 after 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 following one and two months of supplementation. The measurement of the plasma inflammatory markers will be performed by Multiplex assay method.

  5. Changes of Plasma Antioxidant Levels

    Time frame: Baseline, day 30 and day 60 after supplementation

    Antioxidant levels such as Malonaldehyde and Superoxide dismutase will be assessed from the plasma analysis on the fasting blood samples of each participant following one and two months of supplementation. The measurement of the antioxidant levels will be performed by Using ELISA Method.

  6. Incidence of adverse events via evaluation of renal function test

    Time frame: Baseline, day 30 and day 60 after supplementation

    This will be assessed by Kidney Function test from the fasting plasma analysis of each participant following one month and two months supplementation

  7. Incidence of adverse events via evaluation of liver function test

    Time frame: Baseline, day 30 and day 60 after supplementation

    This will be assessed by Liver Function Test from the fasting plasma analysis of each participants following one-month and two-months supplementation

  8. Changes of Body weight measurement

    Time frame: Baseline, day 30 and day 60 after supplementation

    This will be assessed by measuring the weight of each participant. Any drastic change in body weight will indicate non-compliance.

Sponsors and collaborators

Lead sponsor

Isa Naina Mohamed

Other

Collaborators

  • Malaysia Palm Oil Board

Registry information

Official study title

Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia (Phase 2 Clinical Trial Study)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.