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Trial registered on ANZCTR


Registration number
ACTRN12613001041741
Ethics application status
Approved
Date submitted
16/09/2013
Date registered
18/09/2013
Date last updated
14/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Short term effects of palm-tocotrienols and palm-carotenes on vascular function and cardiovascular disease risk in individuals at increased risk of impaired vascular function.
Scientific title
Will short-term supplementation with palm-tocotrienols and palm-carotenes improve endothelial function as measured by brachial artery flow mediated dilation in participants with increased risk of impaired vascular function compared to control?
Secondary ID [1] 283207 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk 290067 0
Type 2 diabetes 290118 0
Impaired fasting glucose 292670 0
Abdominal obesity 293541 0
Condition category
Condition code
Cardiovascular 290449 290449 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 290500 290500 0 0
Diabetes
Alternative and Complementary Medicine 290501 290501 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume one of the following two interventions for a duration of 8 weeks:

* 500mg/d palm tocotrienols in the form of two palm olein capsules/d to be consumed orally with the main meal.

OR

* 21mg/d palm carotenes in the form of three palm olein capsules to be consumed orally with the main meal.

Compliance will be monitored by counting of returned capsules and by measuring plasma tocotrienol and carotenoid concentrations using HPLC.
Intervention code [1] 287932 0
Prevention
Intervention code [2] 287975 0
Treatment: Other
Comparator / control treatment
800mg/d palm olein in the form of two capsules to be consumed orally with the main meal.
Control group
Active

Outcomes
Primary outcome [1] 290475 0
Endothelial function measured by brachial artery flow mediated dilation
Timepoint [1] 290475 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [1] 304576 0
Blood pressure using automated oscillometry
Timepoint [1] 304576 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [2] 304714 0
Glucose metabolism
* Insulin and glucose using plama assays
* Insulin resistance by calculating HOMA2-IR
* HbA1c using HPLC
Timepoint [2] 304714 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [3] 304715 0
Lipid profiles (total cholesterol, HDL-C, LDL-C, triglycerides) using plasma assays
Timepoint [3] 304715 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [4] 304716 0
Plasma inflammatory markers (hs-CRP, IL-6, TNFalpha, adiponectin) using multiplex kits
Timepoint [4] 304716 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [5] 304717 0
Plasma adhesion molecules (ICAM-1, VCAM-1, E-selectin) using multiplex assays
Timepoint [5] 304717 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [6] 304718 0
Endothelium derived fibrinolytic factors:
* tPA using plasma assays
* PAI-1 using mulitplex assays
Timepoint [6] 304718 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [7] 304719 0
Arterial stiffness using pulse wave velocity and augmentation index
Timepoint [7] 304719 0
Baseline, 4 weeks, 8 weeks

Eligibility
Key inclusion criteria
*Male or female
*Type 2 diabetes (previously diagnosed and taking anti-diabetic medication or HbA1c of 7.0-10.0%) or impaired fasting glucose (fasting plasma glucose of 5.6 mmol/L and greater) or abdominal obesity identified by elevated waist circumference: equal of greater than 102 cm (men); equal or greater than 88 cm (women).
*18-70 years
* BMI: 20-45 kg/m2
* No abnormality of clinical significance on medical history
* No history of coronary artery disease or cardiac (heart) abnormalities
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Type 1 diabetes
* Smoking
* Known proteinuria or current malignancy
* Known kidney, respiratory, gastrointestinal, cardiovascular or peripheral vascular disease
* Known abnormal liver function tests
* Known endocrinopathy unless participants are stable on treatment (have been using thyroxine for at least 3 months prior to study commencement (no changes in type and dose) and have no intention to change during study).
* Pregnancy or lactating
* Participated in regular vigorous physical exercise greater than 1 hour per week or greater than 2x, 30 minute sessions / week during the 3 months prior to the study
* Have taken tocotrienol or carotene supplements during the 3 months prior to study
* Taking supplements known to affect outcome measures (i.e. fish oil, vitamin C) unless supplements are ceased before trial commencement (3 months for fish oil, 2 weeks for vitamin C) or participants are stable on the supplements for at least 3 months prior to study commencement (no changes in type and dose) and have no intention to change during study.
* Use of nitrate medication, non-steroidal anti-inflammatory medication (excluding aspirin)
* Taking oral contraceptives or hormone replacement therapy during the 3 months prior to study
* History of heavy alcohol consumption (> 5 STD drinks/day)
* Volunteer unable to limit alcohol consumption for study duration
* Currently on a weight reducing diet or have an eating disorder
* Unwilling to be randomized to either experimental group
* Extended absences due to travel or other commitments
* Unable to comprehend or cope with study requirements

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who are eligible will be enrolled in the project and allocated to an intervention code based on a computer generated randomization scheme. Individuals who enrol and allocate particpants to interventions will be blind to intervention codes. The coded supplements will be concealed by using identical opaque drug containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be assigned to the interventions using stratified random assignment based on diabetic/impaired fasting glucose state, age, gender, weight and medication. The randomization scheme will be computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The power for this study is based on detecting differences for the a priori hypothesis based on comparisons between the palm-carotene vs placebo and palm-tocotrienol vs placebo for the primary outcome measure of FMD. The study will commence with 30 subjects in each group. Based our previous trials, with an anticipate dropout rate of 10% and at least 27 subjects per group completing the study we will have enough power (80%, alpha = 0.05) to detect a minimum absolute difference of 1.8% between the group comparisons for FMD. An improvement in FMD of 2% (absolute) magnitude has previously been associated with a clinically relevant reduction in CVD risk.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2014
Actual
10/06/2014
Date of last participant enrolment
Anticipated
29/05/2015
Actual
5/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287950 0
Commercial sector/Industry
Name [1] 287950 0
Pemandu (Prime Ministers Development of the Goverment of Malaysia) / MPOB (Malaysian Palm oil Board)
Country [1] 287950 0
Malaysia
Primary sponsor type
Government body
Name
CSIRO Animal, Food and Health Sciences
Address
PO Box 10041
Adelaide BC SA 5000
Country
Australia
Secondary sponsor category [1] 286669 0
None
Name [1] 286669 0
Address [1] 286669 0
Country [1] 286669 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289877 0
CSIRO Human Ethics Committee
Ethics committee address [1] 289877 0
Ethics committee country [1] 289877 0
Australia
Date submitted for ethics approval [1] 289877 0
Approval date [1] 289877 0
26/02/2013
Ethics approval number [1] 289877 0
12/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42902 0
Dr Mahinda Abeywardena
Address 42902 0
CSIRO Animal, Food and Health Sciences
PO Box 10041
Adelaide
South Australia
5000
Country 42902 0
Australia
Phone 42902 0
+61 8 8303 8889
Fax 42902 0
Email 42902 0
mahinda.abeywardena@csiro.au
Contact person for public queries
Name 42903 0
Welma Stonehouse
Address 42903 0
CSIRO Animal, Food and Health Sciences
PO Box 10041
Adelaide
South Australia
5000
Country 42903 0
Australia
Phone 42903 0
+61 8 8303 8919
Fax 42903 0
Email 42903 0
welma.stonehouse@csiro.au
Contact person for scientific queries
Name 42904 0
Welma Stonehouse
Address 42904 0
CSIRO Animal, Food and Health Sciences
PO Box 10041
Adelaide
South Australia
5000
Country 42904 0
Australia
Phone 42904 0
+61 8 8303 8919
Fax 42904 0
Email 42904 0
welma.stonehouse@csiro.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort term effects of palm-tocotrienol and palm-carotenes on vascular function and cardiovascular disease risk: A randomised controlled trial.2016https://dx.doi.org/10.1016/j.atherosclerosis.2016.10.027
N.B. These documents automatically identified may not have been verified by the study sponsor.