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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.
Pubmed ID: 29844318
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Register of clinical trials being undertaken in Australia, New Zealand and elsewhere including trials from the full spectrum of therapeutic areas of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies and complementary therapies. In 2007 the ANZCTR was one of the first three trial registries to be recognized by the World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP) as a Primary Registry. WHO recognizes registries as Primary Registries if they fulfill certain criteria with respect to data content, quality and validity, accessibility, unique identification, technical capacity and administration. The ANZCTR contributes data to the WHO ICTRP, which was developed in 2007. Trials from all ICTRP Primary Registries can be searched at: www.who.int/trialsearch Studies should be registered prospectively, i.e. before the first patient is recruited. The registry records a trial's * objectives * main design features * sample size and recruitment status * treatments under investigation * outcomes being assessed * principal investigator * contact person Key points about the ANZCTR * Publicly owned, managed by a not-for-profit organization * All details of trials registered on the ANZCTR are made publicly available * Registration is voluntary, but if a registrant chooses to register a trial, certain fields are mandatory * Registration is free of charge * Responsibility for registration lies with the Sponsor
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