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.
Highlights
Phenolics are believed to be major contributors to the disease-protective effects of fruit and vegetables
Dosage of the oil palm phenolics (OPP) was determined based on the safety and functionality of a similar intake of gallic acid equivalent (GAE) from pomegranate juice
Previous investigation demonstrated that pomegranate dietary supplement is safe when ingested by healthy human volunteers in amounts up to 1420 mg/day, providing a total of 870 mg GAE/day[21]
Summary
Phenolics are believed to be major contributors to the disease-protective effects of fruit and vegetables. Long-term intake of OPP protected healthy, young Nile rats against diabetes onset, as measured by glucose, blood lipids, and weights of livers and kidneys[11]. These outcomes were probably due partly at least to the phenolic compounds in OPP and their protection of ß-cells in the pancreatic islets against oxidative stress, thereby maintaining the integrity and ability of ß-cells to produce insulin[16]. The anti-diabetic potential by OPP supplementation has been postulated to be a result of enhanced insulin sensitivity and reduced glucose absorption/output and not an increase in insulin secretion, as indicated by down-regulation of insulin signaling genes[17]
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