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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01185769
Other study ID # PD141/09
Secondary ID
Status Completed
Phase N/A
First received August 19, 2010
Last updated August 19, 2010
Start date September 2009
Est. completion date September 2009

Study information

Verified date August 2010
Source Malaysia Palm Oil Board
Contact n/a
Is FDA regulated No
Health authority Malaysia: Ministry of Health
Study type Interventional

Clinical Trial 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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 22 Years to 25 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Tocotrienol
500 mg of tocotrienol will be administered after consumption of high fat diet
Tocotrienol
500 mg of tocotrienol will be administered after consumption of low fat diet

Locations

Country Name City State
Malaysia Malaysian Palm Oil Board Bangi Selangor

Sponsors (2)

Lead Sponsor Collaborator
Malaysia Palm Oil Board University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in absorption and distribution of Tocoterienols during high fat and low fat meal by measuring the plasma, chylomicron, and HDL level of tocotrienol 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal No
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