ABSTRACT
Introduction: Oil palm phenolic (OPP) is an antioxidant aqueous palm oil by-product and contains a high amount of phenolics. OPP has been proven to have many therapeutical benefits, and one of them is as an antihyperlipidemic agent. The previous phase 1 clinical trial proved OPP was safe to be orally consumed by healthy volunteers and yielded a good lipid profile. Thus, this phase 2 clinical trial was conducted to determine the effectiveness of OPP in improving the lipid profile among hyperlipidemic subjects. Methods: A parallel, placebo-controlled, randomized, double-blinded clinical trial was conducted for 2 months on 50 hyperlipidemic subjects aged 20-50 years old. The subjects were randomly distributed to two treatment arms with 25 participants each: control/placebo (11 males and 14 females) and 250 mg of OPP (10 males and 15 females). The subjects were required to consume one capsule per day for 60 days. Fasting blood sampling for routine blood profile (hematology, liver function, renal function, and lipid) analysis and a medical examination were conducted at baseline, day 30, and day 60. t-test analysis was used to compare the difference between two test groups. Results: The baseline lipid profile between control group (TC, 5.78 ± 0.52 mmol/L; LDL, 3.88 ± 0.51 mmol/L; HDL, 1.30 ± 0.25; TG, 1.30 ± 0.82), and 250 mg OPP (TC, 5.76 ± 0.54 mmol/L; LDL, 3.82 ± 0.59 mmol/L; HDL, 1.37 ± 0.34; TG, 1.25 ± 0.54) is insignificant. No serious adverse events (SAEs) were reported. No abnormality in fasting blood parameters in all groups was found. Compared to the control group among male participants, the 250 mg OPP group showed an improved serum triglyceride level. There were no statistically significant changes in all blood parameters from day 1 to day 60 with the exception of triglyceride level. Conclusion: The absence of SAEs reported and no abnormal findings in biochemistry and hematology results suggested that the 250 mg OPP was safe to be taken by hyperlipidemic patients with a high probability of reducing triglyceride level in hyperlipidemic male patients The outcomes from this phase II trial suggest that by incorporating OPP supplements into the diet may be a promising strategy for individuals with hyperlipidemia to improve their lipid profiles and reduce cardiovascular risk. However, more research is needed to fully understand the mechanisms of action and establish the long-term efficacy and safety of OPP supplementation in larger scale. Limitation: Small samples size hence lack of diversity (25 subjects per groups) and early sharing of treatment-response results. Clinical Trial Registration: clinicaltrials.gov, identifier NCT04573218.
ABSTRACT
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.
ABSTRACT
CONTEXT: Gynura procumbens (Lour.) Merr. (Asteraceae) has been reported to have various pharmacological activities including anti-inflammatory effects. OBJECTIVE: This study sought to determine whether Gynura procumbens (GP) could improve vascular reactivity by suppressing inflammation in postmenopausal rats fed with five-times heated palm oil (5HPO) diet. MATERIALS AND METHODS: Forty-eight female Sprague-Dawley rats were randomly divided into sham [non-ovariectomized; grouped as control, GP extracts (250 and 500 mg/kg), atorvastatin (ATV, 10 mg/kg)] and postmenopausal (PM) groups [ovariectomized rats fed with 5HPO; grouped as PM, GP extracts (250 and 500 mg/kg) and ATV (10 mg/kg)]. Each group (n = 6) was either supplemented with GP extract or ATV orally once daily for 6 months. RESULTS: In comparison with the untreated PM group, 250 and 500 mg/kg GP supplementation to PM groups reduced the systolic blood pressure (103 ± 2.7, 86 ± 2.4 vs. 156 ± 7.83 mmHg, p < 0.05), intima-media thickness (101.28 ± 3.4, 93.91 ± 2.93 vs. 143.78 ± 3.31 µM), vasoconstriction percentage induced by phenylephrine (102.5%, 88.3%, vs. 51.8%), sICAM-1 (0.49, 0.26 vs. 0.56 pg/mL) and sVCAM-1 (0.39, 0.25 vs. 0.45 pg/mL). GP extract supplementation increased vasorelaxation percentage induced by acetylcholine (78.4% vs. 47.3%) and sodium nitroprusside (84.2% vs. 53.7%), increased changes in plasma nitric oxide level (1.25%, 1.31% vs. 1.9%), and suppressed the elevation of TNF-α (0.39 vs. 1.02 pg/mL), IL-6 (0.43 vs. 0.77 pg/mL) and CRP (0.29 vs. 0.69 ng/mL) in the PM groups. CONCLUSIONS: GP extract might improve vascular dysfunction by suppressing the inflammatory response, consequently preventing blood pressure elevation.
