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Trial registered on ANZCTR


Registration number
ACTRN12618001251213
Ethics application status
Approved
Date submitted
21/06/2018
Date registered
25/07/2018
Date last updated
25/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antioxidant status following postprandial challenge of two different doses of tocopherols and tocotrienols
Scientific title
The postprandial antioxidant potential of vitamin E (alpha-tocopherol and tocotrienols) in humans
Secondary ID [1] 295281 0
PD45/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial 308458 0
Condition category
Condition code
Metabolic and Endocrine 307441 307441 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers were conditioned on a standardized fat-controlled diet (comprising breakfast, lunch and afternoon high tea) for seven days prior to each postprandial intervention during which a-Tocopherol and palm tocotrienol rich-fraction (TRF) supplements at specific doses were administered separately. A one week wash-out period was allowed between each rotation. Corn oil was used as the dietary fat source for meals preparations, and the same menu was repeated for each rotation. Daily food samples were duplicated and analyzed for fat and vitamin E content as well as composition.

Clarification:
Volunteers were provided up to THREE (3) different meals in the fat-controlled diet, per day. The meals were prepared by the trained caterer.

The "Fat-controlled" diet in this study refers to the daily every daily meal provided to volunteers who were recruited into the trial. The meals were prepared by a trained caterer where menus and cooking guidelines were provided by the Investigators. Analysis of fat content on trial samples of the meals were used in drawing up the menu. The most critical part was that, the fat content should provided about 30% of total energy needs and the daily meals should be balanced, containing macronutrients and micronutrients from all of the food groups in the appropriated proportion promoting good health.

Supplementation of vitamin E treatments comprising 268 mg a-Tocopherol, 537 mg a-Tocopherol, 263 mg palm T3 rich-fraction (TRF) or 526 mg TRF. Each volunteers consumed a single acute dose in the morning. Vitamin E supplement was in form of oral tablet. For monitoring compliance, each volunteers consumed the supplementation in front of the Investigator during the postprandial challenge.
Intervention code [1] 301613 0
Other interventions
Comparator / control treatment
Two types of vitamin E were used; (1) alpha-tocopherol, and (2) palm tocotrienols (TRF). Volunteers were challenged with four different treatments of vitamin E preparations in the form of capsules: (1) 263 mg palm TRF, (2) 268 mg a-tocopherol, (3) 526 mg Palm TRF or (4) 537 mg a-tocopherol in a cross-over postprandial trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306405 0
Changes in oxidation products in plasma, namely plasma malondialdehyde (MDA).
Timepoint [1] 306405 0
After 2 hours (h), 4 h, 5h (primary endpoint), 6h, or 8 hours after supplementation of vitamin E treatments (under fasting condition).
Secondary outcome [1] 349055 0
Changes in ferric reducing ability of plasma (FRAP) value; and plasma Trolox-equivalent antioxidany capacity (TEAC) value. Both FRAP and TEAC are composite outcome that reflect the antioxidant potency of the plasma sample against oxidation process in the body.
Timepoint [1] 349055 0
After 2 hours (h), 4 h, 5h, 6h, or 8 hours after supplementation of vitamin E treatments (under fasting condition).
Secondary outcome [2] 349799 0
Changes in plasma total glutathione (GSH) and plasma superoxide dismutase (SOD). Both GSH and SOD are a composite outcome where they are both function as an endogenous enzymatic antioxidants.
Timepoint [2] 349799 0
After 2 hours (h), 4 h, 5h, 6h, or 8 hours after supplementation of vitamin E treatments (under fasting condition).

Eligibility
Key inclusion criteria
All volunteers were healthy, normolipemic, nonsmokers, did not show any clinical symptoms associated with lipid-related cardiovascular disease and none of them consumed any supplements or on medication. For females, they were not pregnant, lactating, or taking contraceptives at the time of enrollment.
Minimum age
19 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking, show any clinical symptoms associated with lipid-related cardiovascular disease, consumed any supplements or on medication. For females, pregnant, lactating, or taking contraceptives at the time of enrollment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The study design enabled each volunteers to serve as an individual control in this cross-over study. Following treatments, each parameter of postprandial response for 8-h period was analyzed for their P trend using Single-factor Repeated Measures Analysis of Variance (ANOVA). Wilcoxon-Signed Ranks Test was performed to detect any significant difference between parameters of interest at specific postprandial interval. Following each postprandial interval (2, 4, 5, 6, 8 and 24 h), outcomes were compared to the corresponding baseline value (0 h) in order to detect any significance following the vitamin E treatments. Changes were calculated as the difference between values at each postprandial interval (2 h to 24 h) and baseline (0 h). Postprandial effects following treatments on plasma profiles were analyzed for their time x treatment interaction, using 2-factor Repeated Measures Analysis of Variance (ANOVA) with an interaction term, in order to detect whether there was a significant difference of postprandial responses between treatments. Area under the curve (AUC), defined as the postprandial antioxidant status responses for the 8-h period with the area normalized to the baseline concentration, and incremental area under the curve (IAUC) was calculated based on the trapezoidal rule. In order to further improve the inter-treatment effects, changes were compared using Wilcoxon Signed Ranks Test. Statistical analyses were performed using Statistical Package for Social Sciences (SPSS®) for WINDOWS software (Version 11.0, SPSS Inc. Chicago, USA) and Excel 2003 (Microsoft Corp. California, USA). SPSS® software was utilized for analyses of Repeated Measures ANOVA and Wilcoxon-Signed Ranks Test. Values were considered significant at P<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10581 0
Malaysia
State/province [1] 10581 0
Selangor

Funding & Sponsors
Funding source category [1] 299873 0
Government body
Name [1] 299873 0
Malaysian Palm Oil Board (MPOB)
Address [1] 299873 0
6, Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor, Malaysia
Country [1] 299873 0
Malaysia
Primary sponsor type
Government body
Name
Malaysian Palm Oil Board (MPOB)
Address
6, Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 299228 0
None
Name [1] 299228 0
Address [1] 299228 0
Country [1] 299228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300744 0
Institutional Ethics Committee of the Malaysian Palm Oil Board (MPOB).
Ethics committee address [1] 300744 0
6, Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor
Ethics committee country [1] 300744 0
Malaysia
Date submitted for ethics approval [1] 300744 0
06/01/2003
Approval date [1] 300744 0
13/01/2003
Ethics approval number [1] 300744 0

Summary
Brief summary
Dietary intake of tocotrienols (T3) were postulated to have a measurable effect on their antioxidant effectiveness It appears that the amount of T3 ingested may not have an impact on plasma antioxidant status. In the current study, the T3 antioxidant effectiveness is believed to be limited by their low uptake or bioavailability in humans. Therefore, we compared the antioxidant effectiveness following postprandial challenge of a-tocopherol or palm T3-rich fraction (TRF) supplementations. We also investigated whether there is a dose-response effect on plasma antioxidant status following various doses of either a-tocopherol or TRF treatments. The dose response effect of plasma antioxidant status was determined from the differences in the total plasma antioxidant status at each postprandial interval (2 h, 4 h, 5 h, 6 h and 8 h).
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 84670 0
Dr Syed Fairus
Address 84670 0
Malaysian Palm Oil Board (MPOB), 6, Persiaran Institusi, Bandar Baru Bangi, 43000, Kajang, Selangor
Country 84670 0
Malaysia
Phone 84670 0
+60387694604
Fax 84670 0
Email 84670 0
syfairus@mpob.gov.my
Contact person for public queries
Name 84671 0
Dr Syed Fairus
Address 84671 0
Malaysian Palm Oil Board (MPOB), 6, Persiaran Institusi, Bandar Baru Bangi, 43000, Kajang, Selangor
Country 84671 0
Malaysia
Phone 84671 0
+60387694604
Fax 84671 0
Email 84671 0
syfairus@mpob.gov.my
Contact person for scientific queries
Name 84672 0
Dr Syed Fairus
Address 84672 0
Malaysian Palm Oil Board (MPOB), 6, Persiaran Institusi, Bandar Baru Bangi, 43000, Kajang, Selangor
Country 84672 0
Malaysia
Phone 84672 0
+60387694604
Fax 84672 0
Email 84672 0
syfairus@mpob.gov.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary