Amir Razak Nor Amira Nabila, Goon Jo Aan, Wan Ngah Wan Zurinah, Makpol Suzana, Ahmad Damanhuri Mohd Hanafi, Ibrahim Nor Faeizah, Abdul Sani Nur Fathiah, Mohd Murshid Nuraqila, Mohd Azizan Anis Faqihah, Chin Kok Yong, Aminuddin Amilia, Mohd Yunus Mohd Heikal, Md Mansor Munirah, Neo Juvenia Rui En, Yap Wei Ney, Loong Hsieu Yen, Ung Yee Wei
Department of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Department of Pharmacology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
JMIR Res Protoc. 2025 Sep 23;14:e73039. doi: 10.2196/73039.
Tocotrienol, a naturally occurring form of vitamin E, has been extensively studied for its potent antioxidant, anti-inflammatory, and immune-stimulating properties. However, the clinical impact of tocotrienol supplementation on older adults' overall health and well-being remains relatively unexplored. This research aims to investigate the efficacy of tocotrienol-rich fraction (TRF) on various health parameters associated with general well-being in individuals aged between 50 years and 75 years.
It is hypothesized that TRF supplementation may exhibit positive outcomes on blood biochemistry and several physiological aspects, including lowered levels of oxidative stress and inflammation biomarkers; improvement in vascular age; and enhancement of skin condition, bone mineral density, and cognitive function.
This randomized, double-blind, placebo-controlled trial was designed to investigate the effectiveness of TRF supplementation on overall health in healthy older adults. The study aims to assess the impact of a daily dosage of 200 mg of TRF over a period of 6 months. A total of 220 participants is enrolled in the study, with one-half receiving the placebo and the other one-half receiving TRF supplementation. The study comprises 3 time points: baseline, 3 months, and 6 months. At each time point, various measurements are taken to evaluate different aspects of health. The primary outcome measurements include blood biochemistry assessments, such as liver function tests, renal profile, lipid profile, and full blood count. Oxidative stress markers, including malondialdehyde, advanced glycation end products, protein carbonyl, and isoprostane, are also evaluated. Immune response markers such as interleukin-6 and tumor necrosis factor-α are assessed. Satiety regulation is examined through measurements of leptin and ghrelin. Body composition and skin health parameters, including wrinkling, pigmentation, elasticity, hydration, and sebum secretion, are evaluated. Additionally, arterial stiffness is assessed using arteriography at baseline and 6 months. For secondary outcome measures, bone mineral density is measured using dual x-ray absorptiometry, and cognitive function is assessed using the Montreal Cognitive Assessment, Rey Auditory Verbal Learning Test, and digital span test. Both bone mineral density and cognitive function are also measured at baseline and 6 months.
The study is progressing as planned, with 209 participants recruited as of April 2025. The research was funded in 2019, and data collection started in December 2020. Preliminary data analysis has been completed for the first 120 participants, and final results are expected upon completion of data collection and unblinding in 2026.
By comprehensively evaluating these health aspects, this study seeks to provide valuable insights into the potential benefits of tocotrienol supplementation for promoting the overall health and well-being of the aging population.
National Medical Research Register (NMRR) NMRR-19-2972-51179; https://tinyurl.com/yy9yueer.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73039.
生育三烯酚是维生素E的一种天然存在形式，因其强大的抗氧化、抗炎和免疫刺激特性而受到广泛研究。然而，补充生育三烯酚对老年人整体健康和幸福的临床影响仍相对未被探索。本研究旨在调查富含生育三烯酚的组分（TRF）对50至75岁个体与总体健康相关的各种健康参数的功效。
假设补充TRF可能在血液生化和几个生理方面呈现积极结果，包括降低氧化应激和炎症生物标志物水平；改善血管年龄；增强皮肤状况、骨矿物质密度和认知功能。
这项随机、双盲、安慰剂对照试验旨在研究补充TRF对健康老年人整体健康的有效性。该研究旨在评估为期6个月、每日服用200毫克TRF的影响。共有220名参与者被纳入研究，其中一半接受安慰剂，另一半接受TRF补充剂。该研究包括3个时间点：基线、3个月和6个月。在每个时间点，进行各种测量以评估健康的不同方面。主要结局测量包括血液生化评估，如肝功能测试、肾功能指标、血脂谱和全血细胞计数。还评估氧化应激标志物，包括丙二醛、晚期糖基化终产物、蛋白质羰基和异前列腺素。评估免疫反应标志物如白细胞介素-6和肿瘤坏死因子-α。通过测量瘦素和胃饥饿素检查饱腹感调节。评估身体成分和皮肤健康参数，包括皱纹、色素沉着、弹性、水合作用和皮脂分泌。此外，在基线和6个月时使用血管造影术评估动脉僵硬度。对于次要结局指标，使用双能X线吸收法测量骨矿物质密度，并使用蒙特利尔认知评估、雷伊听觉词语学习测试和数字广度测试评估认知功能。骨矿物质密度和认知功能也在基线和6个月时进行测量。
该研究按计划进行，截至2025年4月已招募209名参与者。该研究于2019年获得资助，数据收集于2020年12月开始。对前120名参与者的初步数据分析已完成，预计在2026年完成数据收集和揭盲后得出最终结果。
通过全面评估这些健康方面，本研究旨在为补充生育三烯酚对促进老年人群整体健康和幸福的潜在益处提供有价值的见解。
国家医学研究注册库（NMRR）NMRR-19-2972-51179；https://tinyurl.com/yy9yueer。
国际注册报告识别码（IRRID）：DERR1-10.2196/73039。
