A phase i single-blind clinical trial to evaluate the safety of oil palm phenolics (OPP) supplementation in healthy volunteers

Syed Fairus, Soon Sen Leow, Isa Naina Mohamed, Yew Ai Tan, Kalyana Sundram, Ravigadevi Sambanthamurthi

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Plant phenolics are being increasingly consumed globally with limited scientific and clinical evidence pertaining to safety and efficacy. The oil palm fruit contains a cocktail of phenolics, and palm oil production results in high volumes of aqueous by-products enriched in phenolics and bioactives. Several lines of evidence from in vitro and in vivo animal studies confirmed that the aqueous extract enriched in phenolics and other bioactives collectively known as oil palm phenolics (OPP) is safe and has potent bioactivity. A phase one clinical trial was conducted to evaluate the safety and effects of OPP in healthy volunteers. In this single-blind trial, 25 healthy human volunteers were supplemented with 450 mg gallic acid equivalent (GAE)/day of OPP or control treatments for a 60-day period. Fasting blood and urine samples were collected at days 1, 30 and 60. Medical examination was performed during these trial interventions. All clinical biochemistry profiles observed throughout the control and OPP treatment period were in the normal range with no major adverse effect (AE) or serious adverse effect (SAE) observed. Additionally, OPP supplementation resulted in improvement of total cholesterol and LDL-C levels, compared to the control treatment. The outcomes support our previous observations that OPP is safe and may have a protective role in reducing cholesterol levels.

Original languageEnglish
Article number8217
JournalScientific Reports
Volume8
Issue number1
DOIs
Publication statusPublished - 1 Dec 2018

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Healthy Volunteers
Oils
Clinical Trials
Safety
Gallic Acid
Biochemistry
LDL Cholesterol
Fasting
Fruit
Reference Values
Therapeutics
Cholesterol
Urine

ASJC Scopus subject areas

  • General

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A phase i single-blind clinical trial to evaluate the safety of oil palm phenolics (OPP) supplementation in healthy volunteers. / Fairus, Syed; Leow, Soon Sen; Naina Mohamed, Isa; Tan, Yew Ai; Sundram, Kalyana; Sambanthamurthi, Ravigadevi.

In: Scientific Reports, Vol. 8, No. 1, 8217, 01.12.2018.

Research output: Contribution to journalArticle

Fairus, Syed ; Leow, Soon Sen ; Naina Mohamed, Isa ; Tan, Yew Ai ; Sundram, Kalyana ; Sambanthamurthi, Ravigadevi. / A phase i single-blind clinical trial to evaluate the safety of oil palm phenolics (OPP) supplementation in healthy volunteers. In: Scientific Reports. 2018 ; Vol. 8, No. 1.
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