Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 24, 2025
Open Peer Review Period: Mar 5, 2025 - Apr 30, 2025
Date Accepted: Jul 25, 2025
(closed for review but you can still tweet)
The research is approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM) (Ethic number : UKM PPI/111/8/JEP-2019-798), registered with the Malaysia National Medical Research Register (NMRR) and National Pharmaceutical Regulatory Agency (NPRA).
ABSTRACT
Background:
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.
Objective:
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 50-75 years
Methods:
The present study is a randomised, double-blind, placebo-controlled trial designed to investigate the effectiveness of TRF supplementation on overall health in healthy elderly individuals. The study aims to assess the impact of a daily dosage of 200mg of TRF over a period of 6 months. A total of 220 participants are enrolled in the study, with half receiving the placebo and the other half receiving TRF supplementation. The study comprises three endpoints: baseline, 3 months, and 6 months. At each endpoint, various measurements are taken to evaluate different aspects of health. These 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 tumour necrosis factor-alpha 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 by arteriography, bone mineral density is measured using dual x-ray absorptiometry, and cognitive function is assessed through the Montreal Cognitive Assessment, Rey Auditory Verbal Learning Test, and digital span, are measured at baseline and at the 6-month endpoint.
Results:
NIL.
Conclusions:
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 ageing population. Clinical Trial: National Medical Research Register (NMRR), no. NMRR19-2972-51179
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