Study of Tocotrienol Absorption and Distribution Under Different Fat Status

Absorption Clinical Trial

Official title:

Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185769
• Other study ID #: PD141/09
• 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

• Absorption

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