From Safety to Efficacy: Supporting the Clinical Trials of Oil Palm Phenolics

The challenge

Oil palm phenolics (OPP) are a water-based by-product of oil palm fruit processing, rich in plant phenolics. Preclinical research suggested OPP could help lower blood lipids. Before it could reach the market as a supplement, its safety had to be established in people, and its benefit tested in the people it is meant to help.

What Prima Nexus did

The published papers name Prima Nexus as the contract research organisation (CRO) for both trials, which were run at the UKM Medical Centre with funding from the Malaysian Palm Oil Board. To keep the Phase I trial double-blind, the encapsulation, packaging and distribution of the capsules were wholly handled by Prima Nexus as the CRO. In Phase II, the product and placebo capsules were again identically packaged by the CRO.

The Phase I capsules held spray-dried OPP: the liquid extract was produced at the Malaysian Palm Oil Board's phenolics pilot plant, spray-dried by Biotropics Malaysia Berhad and encapsulated by Prima Nexus in Puchong, in halal, plant-based capsules used for both the product and the placebo.

What the studies found

• Phase I, safety (2022): 100 healthy adults aged 20 to 40 took a placebo or 250, 1,000 or 1,500 mg of OPP a day for two months in a randomised, double-blind trial (registered as NCT04164446). There were no serious adverse events and no abnormal blood results, so OPP in capsule form was judged safe up to 1,500 mg a day.
• Phase I, further results (2025): among the 97 volunteers who completed the same trial, 250 mg a day lowered systolic and diastolic blood pressure at day 60 compared with baseline, and 1,500 mg a day improved total antioxidant capacity at day 30. Lipid profiles did not change.
• Phase II (2023): 50 adults with high blood lipids took 250 mg of OPP or a placebo every day for 60 days. The dose was safe, and male participants taking OPP showed an improved triglyceride level.

Why it matters

The programme shows the path a Malaysian natural product travels: preclinical promise, a safety trial in healthy volunteers, then a test in the people it is meant to help. Identical, properly blinded capsules are part of what makes a trial's answer trustworthy, and Prima Nexus handled them for both trials. See our clinical trial support.

In the paper's own words

“Special thanks to MPOB for the project's funding, PPUKM for providing the research venue, Prima Nexus Sdn. Bhd. as the CRO for this trial”

Frontiers in Pharmacology, 2022, Acknowledgments

“To ensure the double-blinded trial was successfully achieved, all the processes involving capsule identification such as encapsulation, packaging, and distribution processes were wholly handled by an appointed contract research organization (CRO).”

Frontiers in Pharmacology, 2022, Methods

“The liquid OPP was produced at the Malaysian Palm Oil Board (MPOB) Phenolics Pilot Plant (Labu, Malaysia), spray-dried by Biotropics Malaysia Berhad (Shah Alam, Malaysia) and encapsulated by Prima Nexus Sdn Bhd (Puchong, Malaysia).”

Scientific Reports, 2025, Methods

About Prima Nexus

Prima Nexus Sdn Bhd is a Malaysian research coordination group founded in 2014. It connects universities, research institutes and global technology partners, and runs eight scientific platforms under one roof: proteomics (including ELISA and Luminex multiplex immunoassays), genomics, flow cytometry, stem cell research, animal research, clinical trials, bioinformatics, and regulatory and grant support. Programmes it coordinates have supported more than 150 papers in peer-reviewed journals and research teams at more than 40 institutions across Malaysia. More about Prima Nexus.