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

Isa Naina Mohamed

Status and phase

Completed

Phase 2

Conditions

Hyperlipidemias

Hypercholesterolemia

Treatments

Dietary Supplement: 250 mg OPP

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04573218

SAPPHIRE

Details and patient eligibility

About

An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate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

Full 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.

Enrollment

50 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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