Evidence map›Paper›PMID 40986853›Full record

ArticleJMIR research protocols2025

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

Nor Amira Nabila Amir Razak, Jo Aan Goon, Wan Zurinah Wan Ngah, Suzana Makpol, Mohd Hanafi Ahmad Damanhuri, Nor Faeizah Ibrahim, Nur Fathiah Abdul Sani, Nuraqila Mohd Murshid, Anis Faqihah Mohd Azizan, Kok Yong Chin and 7 more

Abstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Nor Amira Nabila Amir Razak *Department of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0009-0005-1566-8438
Jo Aan Goon *Department of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0003-1757-3780
Wan Zurinah Wan NgahDepartment of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0001-9363-1650
Suzana MakpolDepartment of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0002-5239-6196
Mohd Hanafi Ahmad DamanhuriDepartment of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0002-6948-8839
Nor Faeizah IbrahimDepartment of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0001-7041-4688
Nur Fathiah Abdul SaniDepartment of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0002-2638-3076
Nuraqila Mohd MurshidDepartment of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0001-6490-8550
Anis Faqihah Mohd AzizanDepartment of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0009-0007-8683-1348
Kok Yong ChinDepartment of Pharmacology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0001-6628-1552
Amilia AminuddinDepartment of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0002-1329-0444
Mohd Heikal Mohd YunusDepartment of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0002-6793-2043
Munirah Md MansorDepartment of Pathology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0000-0002-6500-7823
Juvenia Rui En NeoResearch and Development Department, Davos Life Science, Singapore, Singapore.ORCID 0009-0004-9695-485X
Wei Ney YapResearch and Development Department, Davos Life Science, Singapore, Singapore.ORCID 0000-0002-9108-8567
Hsieu Yen LoongResearch and Development Department, KL-Kepong Oleomas, Selangor, Malaysia.ORCID 0009-0007-7359-4590
Yee Wei UngResearch and Development Department, KL-Kepong Oleomas, Selangor, Malaysia.ORCID 0000-0002-3197-0435

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTocotrienol, 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.

objectiveIt 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.

methodsThis 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.

resultsThe 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.

conclusionsBy 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 registrationNational Medical Research Register (NMRR) NMRR-19-2972-51179; https://tinyurl.com/yy9yueer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73039.

Indexed as

Dietary SupplementsTocotrienolsAgedAntioxidantsBiomarkersBone DensityCognitionDouble-Blind MethodFemaleHumansMaleMiddle AgedOxidative StressRandomized Controlled Trials as TopicAntioxidantsBiomarkersTocotrienolsagingbraincognitionimmuneinflammationoxidative stresssatietyskintocotrienolweight

Identifiers

PMID40986853
PMCPMC12504890

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.