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Study of Tocotrienol Absorption and Distribution Under Different Fat Status

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01185769

First Posted: August 20, 2010

Last Update Posted: August 20, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

University of Malaya

Information provided by:

Malaysia Palm Oil Board

Purpose

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

Condition	Intervention
Absorption	Dietary Supplement: Tocotrienol


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Basic Science
Official Title:	Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status

Resource links provided by NLM:

MedlinePlus related topics: Vitamin E

Drug Information available for: Tocopherol

U.S. FDA Resources

Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:

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 ]


Enrollment:	10
Study Start Date:	September 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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 low fat diet

Detailed Description:

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	22 Years to 25 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185769

Locations


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

Sponsors and Collaborators

Malaysia Palm Oil Board

University of Malaya

Investigators


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

More Information


Responsible Party:	Wong Weng-Yew / Research Officer, Malaysian Palm Oil Board
ClinicalTrials.gov Identifier:	NCT01185769 History of Changes
Other Study ID Numbers:	PD141/09
First Submitted:	August 19, 2010
First Posted:	August 20, 2010
Last Update Posted:	August 20, 2010
Last Verified:	August 2010

Keywords provided by Malaysia Palm Oil Board:


Vitamin E Absorption

Additional relevant MeSH terms:


Tocotrienols Vitamin E Tocopherols Antioxidants Molecular Mechanisms of Pharmacological Action	Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances

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