Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000256774
Ethics application status
Approved
Date submitted
5/10/2021
Date registered
11/02/2022
Date last updated
11/02/2022
Date data sharing statement initially provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Elucidating the Effects of Tocotrienol rich Vitamin E on Metabolic Biomarkers in a Pre-diabetes Population of different ethnicities in Malaysia.
Scientific title
Elucidating the Effects of Tocotrienol rich Vitamin E on Metabolic Biomarkers in a Pre-diabetes Population of different ethnicities in Malaysia.
Secondary ID [1] 305371 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 323719 0
Impaired fasting glucose 324572 0
Impaired Glucose Tolerance 324573 0
Newly diagnosed diabetes 325168 0
Condition category
Condition code
Metabolic and Endocrine 321250 321250 0 0
Diabetes
Metabolic and Endocrine 321251 321251 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 200mg tocotrienol rich Vitamin E from palm oil
Dose: 200mg once daily
Duration: 3 months
Mode of administration: Oral capsule
Active ingredients:
1) Gold Tocotrienol E 70%
2) Yellow palm superolein

Adherence will be assessed by counting the remaining capsule brought back by the participants during the follow-up visits. In addition, the plasma Vitamin E levels will me measured to assess adherence of the participants.
Intervention code [1] 321855 0
Treatment: Drugs
Intervention code [2] 321856 0
Prevention
Comparator / control treatment
This is placebo controlled clinical trial. Each placebo capsule is made up of pure palm oil.
Control group
Placebo

Outcomes
Primary outcome [1] 329129 0
Blood samples will be withdrawn from participants during the visits for data analysis.
Changes in Vitamin E levels (Tocotrienol and Tocopherol) in the blood will measured using high performance liquid chromatography (HPLC).
Timepoint [1] 329129 0
Baseline Visit 1 (o month), visit 2 ( 1st month), visit 3 (3rd month) and visit 4. (6th month)(washout)
Primary outcome [2] 329130 0
Blood samples are withdrawn to measure insulin resistance levels (HOMA-IR) to assess insulin levels and prediabetes state.
Timepoint [2] 329130 0
Baseline Visit 1 (o month), visit 2 ( 1st month), visit 3 (3rd month) and visit 4. (6th month)(washout)
Primary outcome [3] 329131 0
Blood samples are drawn to measure changes in HbA1c levels and other parameters (e.g., fasting lipids, levels of tocopherols, insulin, glucose, and others) to assessed by prediabetes in participants.
Timepoint [3] 329131 0
Baseline Visit 1 (o month), visit 2 ( 1st month), visit 3 (3rd month) and visit 4. (6th month)(washout)
Secondary outcome [1] 401563 0
Blood samples are drawn to measure biomarkers levels (Adiponectin, Glut 4, Resistin) by ELISA.
Timepoint [1] 401563 0
Baseline Visit 1 (o month), visit 3 (3rd month) and visit 4. (6th month)(washout)
Secondary outcome [2] 406009 0
Adverse Effects

a) Participants will be given an adverse effects form that includes history, examination and impression if they have any complaints such as nausea and vomiting. Study PI /doctor will assessed the patients clinically and decide whether these event are related upon taking vitamin E. Patient then will be treated accordingly. Any adverse effect will be documented in the medical records.
Timepoint [2] 406009 0
visit 2 (1st month), visit 3 (3rd month) and visit 4. (6th month)(washout)

Eligibility
Key inclusion criteria
1. Multi-ethnic population in Malaysia namely, Chinese, Malay, Indian and Orang Asli (indigenous population) who are 40 years and above with high risk of Diabetes Mellitus/Pre-diabetes with a FINDRISC Score of 15 and above i.e. risk of diabetes 33%. (Follow the FINDRISC Model)
• A risk score of 15 to 20 points indicates a high risk of diabetes (33% chance of diabetes over 10 years).
• A risk score of greater than 20 points indicate a very high risk of diabetes (50% chance of diabetes over 10 years).
2. Pre-Diabetes criteria: HbA1c: 6.0 to 6.5%.
3. Newly diagnosed diabetes patients ( less than 5 years) with HbA1c equal to 8% and on 2 medications or less and excluding insulin.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. FINDRISC score lower than 15 and HbA1c greater than 6.5% for pre diabetes, and greater than 8.0% for new diabetes
2. Diagnosed diabetes patients for 5 years or more.
3. Fluctuating blood sugar level
• unstable glucose control (more than 10% change in HbA1c levels over the last 2 months)
4. High blood pressure
• poor blood pressure control, BP greater than 160/100
5. Pregnancy
• pregnant during screening
6. Breastfeeding mothers
7. Known diabetic or non-diabetic kidney disease, such as kidney stones etc.
8. Acute or severe chronic illness such as acute coronary syndrome, active tuberculosis, and previous or current history of cancer, liver, or inflammatory disease etc.
9. Taking other vitamins such as Vitamin C or A for the past 1 month
10. Taking other water-soluble antioxidants for the past 2 weeks or fat-soluble antioxidants for the past 1 month
11. Abnormal liver enzyme
• elevated liver enzymes (serum ALT and/or serum AST more than 3 times the upper limit of normal)
12. Participants that are below 40 years old and above 75 years old.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation will be employed in this study. The participants will be stratified according to their gender, age and HbA1c levels. Allocation of subjects will be done by simple randomisation using a randomisation table created by computer software (i.e computerised sequence).
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
Other
Other design features
2 arms Treatment (200 mg) and placebo
4 ethnic groups: Malay, Chinese, Indian, Indigenous
Each group will be divided into a treatment and a placebo arm
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The total sample size of the study is 240 participants. Each cohort (active vs placebo) comprises of 60 participants with an allowance of maximum 2 dropouts per cohort. This number is derived from an online sample size calculator available at: http://clincalc.com/stats/samplesize.aspx.

Statistical analysis such as ANOVA and t-test will be done using SPSS version 25.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 24158 0
Malaysia
State/province [1] 24158 0
Kota Damansara, Selangor
Country [2] 24159 0
Malaysia
State/province [2] 24159 0
Sungai Buloh, Selangor
Country [3] 24160 0
Malaysia
State/province [3] 24160 0
Johor Bahru, Johor

Funding & Sponsors
Funding source category [1] 309742 0
University
Name [1] 309742 0
Monash University Malaysia
Country [1] 309742 0
Malaysia
Funding source category [2] 309812 0
Government body
Name [2] 309812 0
Malaysian Palm Oil Board (MPOB)
Country [2] 309812 0
Malaysia
Primary sponsor type
University
Name
Monash University Malaysia
Address
Jalan Lagoon Selatan,
Bandar Sunway,
47500 Subang Jaya,
Selangor.
Country
Malaysia
Secondary sponsor category [1] 310762 0
Commercial sector/Industry
Name [1] 310762 0
Sime Darby Oils Nutrition Sdn Bhd
Address [1] 310762 0
Batu 9, Jalan Klang-Banting,
Telok Panglima Garang Industrial Estate,
42500 Telok Panglima Garang,
Selangor.
Country [1] 310762 0
Malaysia
Other collaborator category [1] 282010 0
University
Name [1] 282010 0
Universiti Teknologi Mara (UiTM)
Address [1] 282010 0
UiTM Medical Faculty,
Jalan Hospital, Sungai Buloh,
40000, Selangor.
Country [1] 282010 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309498 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 309498 0
Monash Research Office,
26 Sports Walk,
Monash University,
Wellington Road,
Clayton VIC 3800.
Ethics committee country [1] 309498 0
Australia
Date submitted for ethics approval [1] 309498 0
13/11/2020
Approval date [1] 309498 0
14/06/2021
Ethics approval number [1] 309498 0
26262
Ethics committee name [2] 309566 0
UiTM Research Ethics Committee
Ethics committee address [2] 309566 0
Jalan Hospital, Sungai Buloh, 40000, Selangor.
Ethics committee country [2] 309566 0
Malaysia
Date submitted for ethics approval [2] 309566 0
21/09/2021
Approval date [2] 309566 0
Ethics approval number [2] 309566 0

Summary
Brief summary
This is a prospective, multi-centered, randomized, double-blinded ,placebo-controlled study involving patients with prediabetes with a glycemic control between 6.0-6.5% (HbA1c). The primary aim is to establish the potential mechanism of action(s) of the tocotrienol-rich vitamin E on pre-diabetes subjects by assessing levels of HbA1c, insulin resistance and vitamin E .Tocotrienol and tocopherol levels in pre- diabetes population will be measured and compared the Vitamin E isomers levels in normal and diabetes population. Secondly, is to determine whether tocotrienol-rich Vitamin E supplementation at 200mg per day given to pre-diabetes subjects will result in an improvement of insulin resistance and Beta cell function as assessed by the levels of the biomarkers (insulin, resistin, adiponectin and Glut4.) . We hypothesize that Vitamin E supplementation in pre-diabetes population will improve insulin resistance and beta cell function.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114362 0
Dr Badariah Ahmad
Address 114362 0
Monash University Malaysia,
Jalan Lagoon Selatan,
bandar Sunway,
47500 Subang jaya,
Selangor,
Country 114362 0
Malaysia
Phone 114362 0
+60355146310
Fax 114362 0
+60355146000
Email 114362 0
badariah.ahmad@monash.edu
Contact person for public queries
Name 114363 0
Dr Badariah Binti Ahmad
Address 114363 0
Monash University Malaysia,
Jalan Lagoon Selatan,
bandar Sunway,
47500 Subang jaya,
Selangor,
Country 114363 0
Malaysia
Phone 114363 0
+60355146310
Fax 114363 0
+60355146000
Email 114363 0
badariah.ahmad@monash.edu
Contact person for scientific queries
Name 114364 0
Dr Badariah Binti Ahmad
Address 114364 0
Monash University Malaysia,
Jalan Lagoon Selatan,
bandar Sunway,
47500 Subang jaya,
Selangor,
Country 114364 0
Malaysia
Phone 114364 0
+60355146310
Fax 114364 0
+60355146000
Email 114364 0
badariah.ahmad@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.