Supplementation of Oil Palm Phenolics in Healthy Subjects

Conditions

None listed

Brief 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.

Nur Balqis Muhammad Ismail Tadj, Nurul ‘Izzah Ibrahim, Qodriyah Haji Mohd Saad, Tg Mohd Ikhwan Tg Abu Bakar Sidik, Soon-Sen Leow et al. (7 authors)

Frontiers in Pharmacology2022-06-206 citations

10.3389/fphar.2022.893171

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, 2

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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 criteria

Smoking, habitual alcohol consumption, consuming antioxidant supplement, pregnant/ breastfeeding, medical history of cardiovascular disease, diabetes, dyslipidemia, current use of antihypertensive or lipid-lowering medication

Outcome results