Study of Tocotrienol Absorption and Distribution Under Different Fat Status
This study has been completed.
Sponsor:
Malaysia Palm Oil Board
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
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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:
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 (Adult) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01185769
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 | 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 |
| 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 Antioxidants Molecular Mechanisms of Pharmacological Action |
Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on September 26, 2016