Effectiveness of Tocotrienol-Rich Fraction in Older Adults: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial.

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. 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.

Objective: 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.

Methods: 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.

Results: 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.

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 aging population.

Trial registration: National Medical Research Register (NMRR) NMRR-19-2972-51179; https://tinyurl.com/yy9yueer.

International registered report identifier (irrid): DERR1-10.2196/73039.