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Study of Tocotrienol Absorption and Distribution Under Different Fat Status

This study has been completed.
Sponsor:
Collaborator:
University of Malaya
Information provided by:
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01185769
First received: August 19, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   22 Years to 25 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Malaysian Palm Oil Board
  More Information

No publications provided

Responsible Party: Wong Weng-Yew / Research Officer, Malaysian Palm Oil Board
ClinicalTrials.gov Identifier: NCT01185769     History of Changes
Other Study ID Numbers: PD141/09
Study First Received: August 19, 2010
Last Updated: August 19, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by Malaysia Palm Oil Board:
Vitamin E
Absorption

Additional relevant MeSH terms:
Tocotrienols
Vitamin E
Tocopherols
Vitamins
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013