Evidence map›Paper›PMID 26323969›Full record

Trial reportScientific reports2015

A new formulation of Gamma Delta Tocotrienol has superior bioavailability compared to existing Tocotrienol-Rich Fraction in healthy human subjects.

Puvaneswari Meganathan, Rafid Salim Jabir, Ho Gwo Fuang, Nirmala Bhoo-Pathy, Roma Basu Choudhury, Nur Aishah Taib, Kalanithi Nesaretnam, Zamri Chik

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02581085 (Tocotrienol Against the Progression of End Stage Liver Disease), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.7field-weighted citation impact, top 18% of its field
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.

NCT02581085 phase2active not recruitingnot on this mapstarted 2019, after this paper: background citation

Tocotrienol Against the Progression of End Stage Liver Disease

TypeinterventionalSponsorChandan SenRan2019 to 2028Enrolled70ConditionsEnd Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver DiseaseArmsTocotrienol (TCT), Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Biological Properties of Tocotrienols: Evidence in Human Studies.International journal of molecular sciences · 2016
    Review
  9. Article
  10. 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

8 authors at 2 institutions in 1 country.

Puvaneswari MeganathanDepartment of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Rafid Salim JabirDepartment of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Ho Gwo FuangOncology Clinical Unit, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Nirmala Bhoo-PathyDepartment of Social and Preventive Medicine (SPM), Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Roma Basu ChoudhuryClinical Investigation Centre, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Nur Aishah TaibDepartment of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Kalanithi NesaretnamMalaysian Palm Oil Board (MPOB), No. 6 Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor, Malaysia.
Zamri ChikDepartment of Pharmacology, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
University of Malaya · MYMalaysian Palm Oil Board · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Gamma and delta tocotrienols are isomers of Vitamin E with established potency in pre-clinical anti-cancer research. This single-dose, randomized, crossover study aimed to compare the safety and bioavailability of a new formulation of Gamma Delta Tocotrienol (GDT) in comparison with the existing Tocotrienol-rich Fraction (TRF) in terms of gamma and delta isomers in healthy volunteers. Subjects were given either two 300 mg GDT (450 mg γ-T3 and 150 mg δ-T3) capsules or four 200 mg TRF (451.2 mg γ-T3 &102.72 mg δ-T3) capsules and blood samples were taken at several time points over 24 hours. Plasma tocotrienol concentrations were determined using HPLC method. The 90% CI for gamma and delta tocotrienols for the ratio of log-transformation of GDT/TRF for Cmax and AUC0-∞ (values were anti-logged and expressed as a percentage) were beyond the bioequivalence limits (106.21-195.46, 154.11-195.93 and 52.35-99.66, 74.82-89.44 respectively). The Wilcoxon Signed Rank Test for Tmax did not show any significant difference between GDT and TRF for both isomers (p > 0.05). No adverse events were reported during the entire period of study. GDT was found not bioequivalent to TRF, in terms of AUC and Cmax. Gamma tocotrienol in GDT showed superior bioavailability whilst delta tocotrienol showed less bioavailability compared to TRF.

Indexed as

AdultAnalysis of VarianceArea Under CurveBiological AvailabilityChromansChromatography, High Pressure LiquidCross-Over StudiesDrug CompoundingFemaleHalf-LifeHealthy VolunteersHumansIsomerismMaleROC CurveTocotrienolsChromansplastochromanol 8tocotrienol, deltaTocotrienolsVitamin E

Identifiers

PMID26323969
PMCPMC4555096
OpenAlexW1865339461

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.