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

Published on Dec 1, 2018in Scientific Reports4.011
· DOI :10.1038/s41598-018-26384-7
Syed Fairus3
Estimated H-index: 3
(Malaysian Palm Oil Board),
Soon Sen Leow1
Estimated H-index: 1
(Malaysian Palm Oil Board)
+ 3 AuthorsRavigadevi Sambanthamurthi16
Estimated H-index: 16
(Malaysian Palm Oil Board)
Sources
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.
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References39
Newest
#1Soon-Sen Leow (Malaysian Palm Oil Board)H-Index: 7
#2Julia Bolsinger (Brandeis University)H-Index: 4
Last. Ravigadevi Sambanthamurthi (Malaysian Palm Oil Board)H-Index: 16
view all 5 authors...
Background The Nile rat (NR, Arvicanthis niloticus) is a model of carbohydrate-induced type 2 diabetes mellitus (T2DM) and the metabolic syndrome. A previous study found that palm fruit juice (PFJ) delayed or prevented diabetes and in some cases even reversed its early stages in young NRs. However, the molecular mechanisms by which PFJ exerts these anti-diabetic effects are unknown. In this study, the transcriptomic effects of PFJ were studied in young male NRs, using microarray gene expression ...
9 CitationsSource
#1Glen S. Patten (CSIRO: Commonwealth Scientific and Industrial Research Organisation)H-Index: 16
#2Mahinda Y. Abeywardena (CSIRO: Commonwealth Scientific and Industrial Research Organisation)H-Index: 34
Last. Ravigadevi Sambanthamurthi (Malaysian Palm Oil Board)H-Index: 16
view all 5 authors...
Abstract The effects of a novel water soluble polyphenolics preparation (oil palm phenolics; OPP) on whole gastrointestinal transit, ex vivo proximal and distal colonic contractility and intact expulsion time in the distal colon were examined. Nine weeks of dietary supplementation with OPP at 50 mg gallic acid equivalents (GAE)/rat per day had no effect on gastric emptying compared to the control (AIN-93M), but 30% substituted high amylose maize starch (HAMS) used as a positive resistant starch ...
4 CitationsSource
#1Che Anishas Che Idris (UKM: National University of Malaysia)H-Index: 2
#2Tilakavati Karupaiah (UKM: National University of Malaysia)H-Index: 9
Last. Ravigadevi Sambanthamurthi (Malaysian Palm Oil Board)H-Index: 16
view all 8 authors...
Abstract The protective effects of oil palm vitamin E and phenolics against atherosclerosis, either singly or in combination, were studied in an atherogenic rabbit model. Rabbits were either fed atherogenic diet only (CTR), or atherogenic diet with vitamin E (VIT E), or atherogenic diet with oil palm phenolics (OPP), or atherogenic diet with both vitamin E and oil palm phenolics (VIT E + OPP). Results from lipid profile and antioxidant analyses were not significantly different between groups (p ...
14 CitationsSource
#1Julia Bolsinger (Brandeis University)H-Index: 4
#2Andrzej Pronczuk (Brandeis University)H-Index: 22
Last. Kenneth C. Hayes (Brandeis University)H-Index: 33
view all 4 authors...
With the increasing incidence of metabolic diseases, numerous bioactive phytochemicals have been proffered in the dietary prevention of these conditions. Palm fruit juice (PFJ) possesses bioactive phenolic compounds (referred to as oil palm phenolics; OPP) that may deter diabetes. The objective of the present experiments was to document the degree to which PFJ reduces diabetes symptoms in a variety of circumstances in the Nile rat (Arvicanthis niloticus), a novel model for carbohydrate-induced t...
13 CitationsSource
#1Soon-Sen Leow (Malaysian Palm Oil Board)H-Index: 7
#2Shamala Devi Sekaran (UM: University of Malaya)H-Index: 32
Last. Ravigadevi Sambanthamurthi (Malaysian Palm Oil Board)H-Index: 16
view all 5 authors...
Background Water-soluble phenolics from the oil palm possess significant biological properties.
14 CitationsSource
Summary of intervention trials examining the effects of tea consumption on glucose metabolism Author(s), year,reference Study design Intervention Participants Follow-up Measurements ResultsAdverseeventsJosic andcolleagues,2010 28 Randomized,crossover, nonblind300 mL green tea, totalcatechin dose 202 mg,given with test mealn14 (50% men)Age 273yBMI a 22.33.4Healthy patientsEthnicity not reported2 h GlucoseInsulinArea under the curveNo difference in areaunder the curveHigher BGC b at2h( P 0.019) (a...
21 CitationsSource
#1Ravigadevi Sambanthamurthi (Malaysian Palm Oil Board)H-Index: 16
#2YewAi Tan (Malaysian Palm Oil Board)H-Index: 8
Last. Mohd Basri Wahid (Malaysian Palm Oil Board)H-Index: 11
view all 11 authors...
Waste from agricultural products represents a disposal liability, which needs to be addressed. Palm oil is the most widely traded edible oil globally, and its production generates 85 million tons of aqueous by-products annually. This aqueous stream is rich in phenolic antioxidants, which were investigated for their composition and potential in vitro biological activity. We have identified three isomers of caffeoylshikimic acid as major components of oil palm phenolics (OPP). The 2,2-diphenyl-1-p...
34 CitationsSource
#1Ravigadevi Sambanthamurthi (Malaysian Palm Oil Board)H-Index: 16
#2YewAi Tan (Malaysian Palm Oil Board)H-Index: 8
Last. Mohd Basri Wahid (Malaysian Palm Oil Board)H-Index: 11
view all 13 authors...
It is well established that plant phenolics elicit various biological activities, with positive effects on health. Palm oil production results in large volumes of aqueous by-products containing phenolics. In the present study, we describe the effects of oil palm phenolics (OPP) on several degenerative conditions using various animal models. OPP reduced blood pressure in a NO-deficient rat model, protected against ischaemia-induced cardiac arrhythmia in rats and reduced plaque formation in rabbit...
20 CitationsSource
#1Soon-Sen Leow (Malaysian Palm Oil Board)H-Index: 7
#2Shamala Devi Sekaran (UM: University of Malaya)H-Index: 32
Last. Ravigadevi Sambanthamurthi (Malaysian Palm Oil Board)H-Index: 16
view all 5 authors...
Background Plant phenolics are important nutritional antioxidants which could aid in overcoming chronic diseases such as cardiovascular disease and cancer, two leading causes of death in the world. The oil palm (Elaeis guineensis) is a rich source of water-soluble phenolics which have high antioxidant activities. This study aimed to identify the in vivo effects and molecular mechanisms involved in the biological activities of oil palm phenolics (OPP) during healthy states via microarray gene exp...
16 CitationsSource
#1Mary Foong-Fong Chong (University of Reading)H-Index: 4
#2Rory Macdonald (University of Reading)H-Index: 1
Last. Julie A. Lovegrove (University of Reading)H-Index: 43
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Epidemiological evidence suggests that polyphenols may, in part, explain the cardioprotective properties of fruits. This review aims to summarise the evidence for the effects of fruit polyphenols on four risk factors of CVD: platelet function, blood pressure, vascular function and blood lipids. This review includes human dietary intervention studies investigating fruits and their polyphenols. There was some evidence to suggest that fruits containing relatively high concentrations of flavonols, a...
173 CitationsSource
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