NCT01185769

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
Last Updated

August 20, 2010

Status Verified

August 1, 2010

Enrollment Period

Same day

First QC Date

August 19, 2010

Last Update Submit

August 19, 2010

Conditions

Absorption

Keywords

Vitamin EAbsorption

Outcome Measures

Primary Outcomes (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

    0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal

Study Arms (2)

High fat

EXPERIMENTAL

500 mg of tocotrienol will be administered at single dose after consumption of high fat diet

Dietary Supplement: Tocotrienol

Low fat

EXPERIMENTAL

500 mg of tocotrienol will be administered at single dose after consumption of low fat diet

Dietary Supplement: Tocotrienol

Interventions

TocotrienolDIETARY_SUPPLEMENT

500 mg of tocotrienol will be administered after consumption of high fat diet

High fat

Eligibility Criteria

Age22 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male aged 22-25
  • body mass index 18.5 \< X \< 30 kg/m2
  • plasma cholesterol \< 5.2 mmol/L,
  • TAG \< 1.7 mmol/L

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysian Palm Oil Board

Bangi, Selangor, 43000, Malaysia

Location

MeSH Terms

Interventions

Tocotrienols

Intervention Hierarchy (Ancestors)

Vitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Weng-Yew Wong, Bsc

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 20, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 20, 2010

Record last verified: 2010-08

Locations

MY(1)