NCT01571921

Brief Summary

Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written informed consent to participate in the trial will be recruited to compare the rate and extent of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

Same day

First QC Date

March 26, 2012

Last Update Submit

September 13, 2016

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Peak Plasma Concentration (Cmax)of drug

    0 to 24 hours after dosing

Study Arms (2)

Gamma-Delta Tocotrienol

EXPERIMENTAL
Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction

TRF

ACTIVE COMPARATOR
Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction

Interventions

Gamma-Delta Tocotrienol and Tocotrienol Rich FractionDIETARY_SUPPLEMENT

Single oral TRF or Gamma-Delta Tocotrienol dosage

Gamma-Delta TocotrienolTRF

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female aged 21-55 years old
  • Good health
  • No allergy to vitamin E/ palm oil
  • No past (within 3 months) / current use of dietary supplements containing vitamin E

You may not qualify if:

  • History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers
  • Candidate for surgery or had undergone surgery in the past 6 months
  • Current or past use (last 3 months) of antithrombotic drugs such as antiplatelets (aspirin, ticlopidine), anticoagulants (heparin, warfarin), thrombolytic agents (streptokinase), etc
  • Current or past history of cancer
  • Pregnant/ breastfeeding women
  • Smokers
  • Drug or alcohol abuse
  • Hypercholesterolemia
  • Chronic conditions such as uncontrolled hypertension, heart disease (ischemic heart disease, heart failure, cardiac arrhythmia), uncontrolled diabetes, HIV infection, or other psychiatric illness/ social situations that might limit adherence to study protocol.
  • Unable or unwilling to stop taking vitamins, herbal preparations or nonprescription medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre(UMMC)

Lembah Pantai,, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (6)

  • Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.

    PMID: 22298568BACKGROUND

  • Mahalingam D, Radhakrishnan AK, Amom Z, Ibrahim N, Nesaretnam K. Effects of supplementation with tocotrienol-rich fraction on immune response to tetanus toxoid immunization in normal healthy volunteers. Eur J Clin Nutr. 2011 Jan;65(1):63-9. doi: 10.1038/ejcn.2010.184. Epub 2010 Sep 22.

    PMID: 20859299BACKGROUND

  • Zaiden N, Yap WN, Ong S, Xu CH, Teo VH, Chang CP, Zhang XW, Nesaretnam K, Shiba S, Yap YL. Gamma delta tocotrienols reduce hepatic triglyceride synthesis and VLDL secretion. J Atheroscler Thromb. 2010 Oct 27;17(10):1019-32. doi: 10.5551/jat.4911. Epub 2010 Aug 10.

    PMID: 20702976BACKGROUND

  • Comitato R, Nesaretnam K, Leoni G, Ambra R, Canali R, Bolli A, Marino M, Virgili F. A novel mechanism of natural vitamin E tocotrienol activity: involvement of ERbeta signal transduction. Am J Physiol Endocrinol Metab. 2009 Aug;297(2):E427-37. doi: 10.1152/ajpendo.00187.2009. Epub 2009 Jun 2.

    PMID: 19491296BACKGROUND

  • Weng-Yew W, Selvaduray KR, Ming CH, Nesaretnam K. Suppression of tumor growth by palm tocotrienols via the attenuation of angiogenesis. Nutr Cancer. 2009;61(3):367-73. doi: 10.1080/01635580802582736.

    PMID: 19373610BACKGROUND

  • Nesaretnam K, Selvaduray KR, Abdul Razak G, Veerasenan SD, Gomez PA. Effectiveness of tocotrienol-rich fraction combined with tamoxifen in the management of women with early breast cancer: a pilot clinical trial. Breast Cancer Res. 2010;12(5):R81. doi: 10.1186/bcr2726. Epub 2010 Oct 8.

    PMID: 20929592RESULT

Study Officials

  • Nur Aishah Mohd Taib

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

March 26, 2012

First Posted

April 5, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

MY(1)