A Phase I, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Tolerance of Oil Palm Phenolics (OPP) in Healthy Volunteers

Abstract

Background and aim: Oil palm aqueous by-products rich in phenolic content are known as oil palm phenolics (OPP), and pre-clinical research has shown that OPP has great potential to be further developed as an anti-hyperlipidemic agent. Hence, in order to introduce OPP into market, its safety profile needs to be established by undergoing a phase I clinical trial on healthy humans. Methods: A parallel, placebo-controlled, randomized, and double-blinded clinical trial was conducted for 2 months on 100 healthy subjects aged 20-40 years old. This trial was registered at clinicaltrials.gov (NCT04164446). The subjects were randomly allocated to four treatment arms with 25 participants each: placebo, 250, 1,000, and 1,500 mg of OPP. During the trial, subjects were required to consume four capsules simultaneously per day. Withdrawal of fasting blood for hematology, liver and renal function analysis, and medical examination were conducted at baseline (day 1), day 30, and day 60. For monitoring, vital signs (blood pressure and pulse rate) and weight measurements were taken during each visit. Results: Minor adverse events (AEs) were reported in all groups especially at high dose (1,500 mg) but none were serious adverse events (SAEs). Fasting blood parameters between control and all OPP-treated groups demonstrated no statistically significant difference from baseline to day 60. Conclusion: With no major AEs and SAEs reported and no abnormal findings in biochemistry and hematology results, OPP supplementation in capsule form is safe to be taken up to 1,500 mg a day.

Keywords: antihyperlipidemia; antioxidant; clinical trial (CT); natural products; oil palm phenolics; safety and toxicology.