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Trial registered on ANZCTR


Registration number
ACTRN12619001786189
Ethics application status
Approved
Date submitted
6/11/2019
Date registered
17/12/2019
Date last updated
17/12/2019
Date data sharing statement initially provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Supplementation of Oil Palm Phenolics in Healthy Subjects
Scientific title
Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Healthy Subjects (Phase I Clinical Trial Study)
Secondary ID [1] 299722 0
NIL
Universal Trial Number (UTN)
U1111-1243-0278
Trial acronym
SOPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 315069 0
Hyperlipidaemia 315070 0
Condition category
Condition code
Metabolic and Endocrine 313405 313405 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each volunteer will be supplemented with two capsules containing oil palm phenolics (OPP) or placebo, once a day (morning) for 2 months (60 days). The volunteers will be randomly allocated to the following groups:
Arm 1 - Placebo (two capsules of placebo)
Arm 2 - 250 mg OPP (two capsules; 1 placebo capsule and 1 250mg OPP capsule)
Arm 3 - 1000 mg OPP (two capsules; 1 placebo capsule and 1 1g OPP capsule)
Arm 4 - 2000 mg OPP (two capsules; 2 1g OPP capsules)
*One capsule may contain: placebo, 250 mg OPP or 1 g OPP

The volunteer will be required to come to the clinical trial ward daily for the first 2 weeks (Mondays to Fridays), for physical examinations and they need to take the capsule in front of the study staff. The volunteer will be required to come once a week for the remaining trial period (6 weeks) and will be supplemented with capsules in a medication bottle. In monitoring adherence to the intervention, a subject diary will be provided and capsule counting from the medication bottle returned by volunteers will be performed.



Intervention code [1] 315986 0
Treatment: Other
Intervention code [2] 315987 0
Prevention
Comparator / control treatment
Placebo is made from starch and glucose. The placebo will be formulated the same as the OPP capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 321883 0
The primary outcome is to observe changes in fasting plasma LDL cholesterol level. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer (at day 0, day 30, day 60).
Timepoint [1] 321883 0
The changes can be observed from the plasma analysis at day 30 and day 60 after supplementation.
Primary outcome [2] 321884 0
Evaluation of the safety and tolerability profile. This will be assessed via kidney function test, liver function test and haematology profile from the plasma analysis on the fasting blood samples of each volunteer (at day 0, day 30, day 60)
Timepoint [2] 321884 0
The safety and tolerability profile can be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [1] 376592 0
The secondary outcome is to observe changes in fasting lipid profile (total and HDL cholesterol, triacylglycerides). This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [1] 376592 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [2] 376618 0
The secondary outcome is to observe changes in fasting LDL cholesterol subfractions. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [2] 376618 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [3] 377764 0
The secondary outcome is to observe changes in fasting HDL cholesterol subfractions. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [3] 377764 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [4] 377765 0
The exploratory outcome is to observe changes in the concentrations of plasma inflammatory marker IL-6. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [4] 377765 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [5] 377912 0
The exploratory outcome is to observe changes in the concentrations of plasma inflammatory marker IL-1 beta. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [5] 377912 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [6] 377917 0
The exploratory outcome is to observe changes in the concentrations of plasma inflammatory marker TNF-alpha. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [6] 377917 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [7] 377918 0
The exploratory outcome is to observe changes in the concentrations of plasma inflammatory marker IL-10. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [7] 377918 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [8] 377919 0
The exploratory outcome is to observe changes in the concentrations of plasma inflammatory marker interferon-gamma
Timepoint [8] 377919 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [9] 377920 0
The exploratory outcome is to observe changes in the antioxidant enzyme level (MDA). This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [9] 377920 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [10] 377921 0
The exploratory outcome is to observe changes in the antioxidant enzyme level (SOD). This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [10] 377921 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.
Secondary outcome [11] 377922 0
The exploratory outcome is to observe changes in the antioxidant enzyme level (iNOS). This will be assessed from the plasma analysis on the fasting blood samples of each volunteer at day 0, day 30 and day 60.
Timepoint [11] 377922 0
The changes will be observed from the plasma analysis at day 30 and day 60 after supplementation.

Eligibility
Key inclusion criteria
Healthy, normal levels of lipid profile (Total cholesterol less than 5.2 mmol/dL, LDL cholesterol less than 3.36 mmol/dL, Triglycerides less than 1.69 mmol/dL)
Minimum age
20 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking, habitual alcohol consumption, consuming antioxidant supplement, pregnant/ breastfeeding, medical history of cardiovascular disease, diabetes, dyslipidemia, current use of antihypertensive or lipid-lowering medication

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The sample size calculation for RCT for each arm for parallel trial is based on Zhong 2009:
a= type 1 error rate = 0.05
ß=type 2 error rate = 0.2 (power = 0.8)
p1= expected event rate in control group = 0.1
p2= expected event rate in treatment group = 0.5
N = 19 subjects in each arm

For this study, we have targeted to obtain 100 subjects (25 in each arm), to ensure a sufficient sample size in the case of subjects’ withdrawal.

Reference : Zhong B. How to calculate sample size in randomized controlled trial?. J Thorac Dis. 2009;1(1):51–54.


Recruitment
Recruitment status
Not yet recruiting
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] 22012 0
Malaysia
State/province [1] 22012 0
WP KUALA LUMPUR

Funding & Sponsors
Funding source category [1] 304192 0
Government body
Name [1] 304192 0
Economic Planning Unit. Prime Minister’s Department. Malaysia
Address [1] 304192 0
Level –1, Block B5, Federal Government Administrative Centre, 62502 Putrajaya.
Country [1] 304192 0
Malaysia
Primary sponsor type
Government body
Name
Economic Planning Unit. Prime Minister’s Department. Malaysia
Address
Level –1, Block B5, Federal Government Administrative Centre, 62502 Putrajaya.
Country
Malaysia
Secondary sponsor category [1] 304424 0
Government body
Name [1] 304424 0
Malaysian Palm Oil Board
Address [1] 304424 0
6, Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor.
Country [1] 304424 0
Malaysia
Other collaborator category [1] 281019 0
University
Name [1] 281019 0
National University of Malaysia/ Universiti Kebangsaan Malaysia (UKM)
Address [1] 281019 0
Pharmacology Department, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras,Kuala Lumpur.
Country [1] 281019 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304662 0
Research Ethics Committee, The National University of Malaysia
Ethics committee address [1] 304662 0
1st Floor, Clinical Block, Hospital Canselor Tunku Mukhriz, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur.
Ethics committee country [1] 304662 0
Malaysia
Date submitted for ethics approval [1] 304662 0
Approval date [1] 304662 0
11/04/2019
Ethics approval number [1] 304662 0
JEP-2019-100

Summary
Brief summary
Oil Palm Phenolics (OPP) is a filtrate produced from the aqueous waste stream during palm oil milling process. In a preliminary study, OPP supplementation to hamster model demonstrated an improvement in lipid profile, which may prevent or delay the development of cardiovascular diseases. This clinical study will be performed to determine the safety and tolerability for the lipid-lowering effect in healthy subjects. Under human physiological conditions, OPP may exhibit a good safety and tolerability profile, as well as improvement in lipid profile, antioxidant and anti-inflammatory status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97766 0
A/Prof Isa Naina Mohamed
Address 97766 0
Pharmacology Department, 17th Level, Pre-Clinical Block, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras 56000 Kuala Lumpur
Country 97766 0
Malaysia
Phone 97766 0
+60391459568
Fax 97766 0
Email 97766 0
isanaina@ppukm.ukm.edu.my
Contact person for public queries
Name 97767 0
Dr Nurul Izzah Ibrahim
Address 97767 0
Pharmacology Department, 17th Level, Pre-Clinical Block, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras 56000 Kuala Lumpur
Country 97767 0
Malaysia
Phone 97767 0
+60132678770
Fax 97767 0
Email 97767 0
nurulizzah@ukm.edu.my
Contact person for scientific queries
Name 97768 0
A/Prof Isa Naina Mohamed
Address 97768 0
Pharmacology Department, 17th Level, Pre-Clinical Block, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras 56000 Kuala Lumpur
Country 97768 0
Malaysia
Phone 97768 0
+60391459568
Fax 97768 0
Email 97768 0
isanaina@ppukm.ukm.edu.my

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?
No other documents available
Summary results
No Results