PMID- 35795564
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 13
DP  - 2022
TI  - A Phase I, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to 
      Evaluate the Safety and Tolerance of Oil Palm Phenolics (OPP) in Healthy 
      Volunteers.
PG  - 893171
LID - 10.3389/fphar.2022.893171 [doi]
LID - 893171
AB  - 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.
CI  - Copyright (c) 2022 Muhammad Ismail Tadj, Ibrahim, Haji Mohd Saad, Tg Abu Bakar 
      Sidik, Leow, Fairus and Naina Mohamed.
FAU - Muhammad Ismail Tadj, Nur Balqis
AU  - Muhammad Ismail Tadj NB
AD  - Pharmacoepidemiology and Drug Safety Unit, Department of Pharmacology, Faculty of 
      Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
FAU - Ibrahim, Nurul 'Izzah
AU  - Ibrahim N'
AD  - Pharmacoepidemiology and Drug Safety Unit, Department of Pharmacology, Faculty of 
      Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
FAU - Haji Mohd Saad, Qodriyah
AU  - Haji Mohd Saad Q
AD  - Pharmacoepidemiology and Drug Safety Unit, Department of Pharmacology, Faculty of 
      Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
FAU - Tg Abu Bakar Sidik, Tg Mohd Ikhwan
AU  - Tg Abu Bakar Sidik TMI
AD  - Pharmacoepidemiology and Drug Safety Unit, Department of Pharmacology, Faculty of 
      Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
FAU - Leow, Soon-Sen
AU  - Leow SS
AD  - Malaysian Palm Oil Board (MPOB), Kajang, Malaysia.
FAU - Fairus, Syed
AU  - Fairus S
AD  - Malaysian Palm Oil Board (MPOB), Kajang, Malaysia.
FAU - Naina Mohamed, Isa
AU  - Naina Mohamed I
AD  - Pharmacoepidemiology and Drug Safety Unit, Department of Pharmacology, Faculty of 
      Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
LA  - eng
SI  - ClinicalTrials.gov/NCT04164446
PT  - Journal Article
DEP - 20220620
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC9251303
OTO - NOTNLM
OT  - antihyperlipidemia
OT  - antioxidant
OT  - clinical trial (CT)
OT  - natural products
OT  - oil palm phenolics
OT  - safety and toxicology
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/07/08 06:00
MHDA- 2022/07/08 06:01
PMCR- 2022/06/20
CRDT- 2022/07/07 02:31
PHST- 2022/03/11 00:00 [received]
PHST- 2022/04/20 00:00 [accepted]
PHST- 2022/07/07 02:31 [entrez]
PHST- 2022/07/08 06:00 [pubmed]
PHST- 2022/07/08 06:01 [medline]
PHST- 2022/06/20 00:00 [pmc-release]
AID - 893171 [pii]
AID - 10.3389/fphar.2022.893171 [doi]
PST - epublish
SO  - Front Pharmacol. 2022 Jun 20;13:893171. doi: 10.3389/fphar.2022.893171. 
      eCollection 2022.