Study of Tocotrienol Absorption and Distribution Under Different Fat Status

August 19, 2010 updated by: Malaysia Palm Oil Board

Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status

Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans remains unclear especially with different fat diets.This study aimed at evaluating the absorption and distribution of tocotrienols in plasma and lipoproteins in associations with high and low fat diets. Different fat level will affect the absorption and distribution of tocotrienols

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a possibility that the absorption and distribution of tocotrienols may occur differently compared with tocopherols, especially under different fat status

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Bangi, Selangor, Malaysia, 43000
        • Malaysian Palm Oil Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male aged 22-25
  • body mass index 18.5 < X < 30 kg/m2
  • plasma cholesterol < 5.2 mmol/L,
  • TAG < 1.7 mmol/L

Exclusion Criteria:

  • history of cardiovascular disease
  • diabetic
  • body mass index < 18.5 or > 30 kg/m2
  • plasma cholesterol > 5.2 mmol/L,
  • TAG > 1.7 mmol/L
  • hypertension
  • currently taking Vitamin E supplement
  • current use of medication
  • smoking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High fat
500 mg of tocotrienol will be administered at single dose after consumption of high fat diet
Dietary supplement: Tocotrienol
500 mg of tocotrienol will be administered after consumption of high fat diet
Dietary supplement: Tocotrienol
500 mg of tocotrienol will be administered after consumption of low fat diet
Experimental: Low fat
500 mg of tocotrienol will be administered at single dose after consumption of low fat diet
Dietary supplement: Tocotrienol
500 mg of tocotrienol will be administered after consumption of high fat diet
Dietary supplement: Tocotrienol
500 mg of tocotrienol will be administered after consumption of low fat diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in absorption and distribution of Tocoterienols during high fat and low fat meal by measuring the plasma, chylomicron, and HDL level of tocotrienol
Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal
0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malaysia Palm Oil Board

Collaborators

University of Malaya

Investigators

  • Principal Investigator: Weng-Yew Wong, Bsc, Malaysia Palm Oil Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 20, 2010

Study Record Updates

Last Update Posted (Estimate)

August 20, 2010

Last Update Submitted That Met QC Criteria

August 19, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD141/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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