Supplementation of Oil Palm Phenolics in Healthy Subjects
Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Healthy Subjects (Phase I Clinical Trial Study)
Economic Planning Unit. Prime Minister’s Department. Malaysia
100 participants
Jan 1, 2020
Interventional
Conditions
Summary
Oil Palm Phenolics (OPP) is a filtrate produced from the aqueous waste stream during palm oil milling process. In a preliminary study, OPP supplementation to hamster model demonstrated an improvement in lipid profile, which may prevent or delay the development of cardiovascular diseases. This clinical study will be performed to determine the safety and tolerability for the lipid-lowering effect in healthy subjects. Under human physiological conditions, OPP may exhibit a good safety and tolerability profile, as well as improvement in lipid profile, antioxidant and anti-inflammatory status.
Eligibility
Inclusion Criteria1
- Healthy, normal levels of lipid profile (Total cholesterol less than 5.2 mmol/dL, LDL cholesterol less than 3.36 mmol/dL, Triglycerides less than 1.69 mmol/dL)
Exclusion Criteria1
- Smoking, habitual alcohol consumption, consuming antioxidant supplement, pregnant/ breastfeeding, medical history of cardiovascular disease, diabetes, dyslipidemia, current use of antihypertensive or lipid-lowering medication
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Interventions
Each volunteer will be supplemented with two capsules containing oil palm phenolics (OPP) or placebo, once a day (morning) for 2 months (60 days). The volunteers will be randomly allocated to the following groups: Arm 1 - Placebo (two capsules of placebo) Arm 2 - 250 mg OPP (two capsules; 1 placebo capsule and 1 250mg OPP capsule) Arm 3 - 1000 mg OPP (two capsules; 1 placebo capsule and 1 1g OPP capsule) Arm 4 - 2000 mg OPP (two capsules; 2 1g OPP capsules) *One capsule may contain: placebo, 250 mg OPP or 1 g OPP The volunteer will be required to come to the clinical trial ward daily for the first 2 weeks (Mondays to Fridays), for physical examinations and they need to take the capsule in front of the study staff. The volunteer will be required to come once a week for the remaining trial period (6 weeks) and will be supplemented with capsules in a medication bottle. In monitoring adherence to the intervention, a subject diary will be provided and capsule counting from the medication bottle returned by volunteers will be performed.
Locations(1)
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ACTRN12619001786189