Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Sunway, Selangor, 47500, Malaysia.
Product Development and Advisory Services, Malaysian Palm Oil Board, Bandar Baru Bangi, Selangor, 43650, Malaysia.
F1000Res. 2024 Feb 22;13:135. doi: 10.12688/f1000research.137005.1. eCollection 2024.
Vitamin E from palm oil, known as the tocotrienol-rich fraction (TRF), has been shown to have immune-enhancing activity. To date, only one dose of TRF (400 mg daily) has been tested in a clinical trial. The proposed study will evaluate the immune-enhancing activity effects of lower doses (200, 100 and 50 mg) in a clinical trial using an influenza vaccine as the immunological challenge.
A single-centre, randomised, parallel, double-blinded, placebo-controlled clinical trial with balance allocation involving five arms will be conducted. The healthy volunteers recruited will be randomly assigned to one of the arms, and they will be asked to take the respective supplements (400 mg, 200 mg, 100 mg, 50 mg of TRF or placebo) daily with their dinner. The volunteers will receive the influenza vaccine after four weeks. They will be asked to return to the study site four weeks later. A blood sample will be taken for the study at baseline, four and eight weeks. Primary outcome measures will be antibody levels to influenza, blood leucocyte profile and cytokine production. Secondary outcomes will be correlating plasma vitamin E levels with immune responses, plasma proteins and gene expression patterns. The findings from this study will be published in relevant peer-reviewed journals and presented at relevant national and international scientific meetings.
The recent world events have created the awareness of having a healthy and functional immune system. Nutrition plays an important role in helping the immune system to function optimally. This study will show the effects of lower doses of TRF in boosting the immune response of healthy individuals and also elucidate the mechanisms through which TRF exerts its immune-enhancing effects.
Australian New Zealand Clinical Trials Registry (ANZCTR) [ ACTRN12622000844741] dated 15 June 2022.
来自棕榈油的维生素 E，即富含生育三烯酚（TRF）的部分，已被证明具有增强免疫的活性。迄今为止，仅在一项临床试验中测试了 TRF 的一个剂量（每天 400 毫克）。拟议的研究将使用流感疫苗作为免疫挑战，在临床试验中评估较低剂量（200、100 和 50 毫克）的免疫增强活性效应。
将进行一项单中心、随机、平行、双盲、安慰剂对照临床试验，采用平衡分配法，共设五个组。招募的健康志愿者将被随机分配到其中一组，并要求他们每天随晚餐服用相应的补充剂（400 毫克、200 毫克、100 毫克、50 毫克 TRF 或安慰剂）。四周后，志愿者将接种流感疫苗。四周后，他们将被要求返回研究现场。在基线、四周和八周时，将进行血液样本研究。主要观察指标为流感抗体水平、血液白细胞谱和细胞因子产生。次要结果将是将血浆维生素 E 水平与免疫反应、血浆蛋白和基因表达模式相关联。本研究的结果将发表在相关的同行评议期刊上，并在相关的国家和国际科学会议上报告。
最近的世界事件使人们意识到拥有健康和功能正常的免疫系统的重要性。营养在帮助免疫系统发挥最佳功能方面起着重要作用。本研究将显示较低剂量 TRF 对增强健康个体免疫反应的作用，并阐明 TRF 发挥其免疫增强作用的机制。
澳大利亚新西兰临床试验注册中心（ANZCTR）[ACTRN12622000844741]，日期为 2022 年 6 月 15 日。
2。
