Effectiveness of Tocotrienol-Rich Fraction in Older Adults: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,018 | 0,018 |
| Méta-épidémiologie (sens strict) | 0,006 | 0,003 |
| Méta-épidémiologie (sens large) | 0,014 | 0,005 |
| Bibliométrie | 0,002 | 0,003 |
| Études des sciences et des technologies | 0,003 | 0,003 |
| Communication savante | 0,003 | 0,004 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,008 | 0,007 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,051 | 0,009 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».