Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia
Condition: Hyperlipidemias; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

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      An unpublished study by the investigators on healthy participants has shown that the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.
    

Intervention name(s): Placebo; 250 mg OPP
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): The placebo contains glucose; 250 mg Oil Palm Phenolics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: oil palm phenolics; lipid profile