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Study of Tocotrienol Absorption and Distribution Under Different Fat Status

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ClinicalTrials.gov Identifier: NCT01185769
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : August 20, 2010
Sponsor:
Collaborator:
University of Malaya
Information provided by:
Malaysia Palm Oil Board

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Absorption Dietary Supplement: Tocotrienol Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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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
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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
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Malaysia
Malaysian Palm Oil Board
Bangi, Selangor, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
University of Malaya
Investigators
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Principal Investigator: Weng-Yew Wong, Bsc Malaysia Palm Oil Board
More Information
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Responsible Party: Wong Weng-Yew / Research Officer, Malaysian Palm Oil Board
ClinicalTrials.gov Identifier: NCT01185769    
Other Study ID Numbers: PD141/09
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: August 20, 2010
Last Verified: August 2010
Keywords provided by Malaysia Palm Oil Board:
Vitamin E
Absorption
Additional relevant MeSH terms:
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Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients