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Trial registered on ANZCTR


Registration number
ACTRN12611001122943
Ethics application status
Approved
Date submitted
22/10/2011
Date registered
27/10/2011
Date last updated
5/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Palm Fruit Juice Supplementation in Healthy Volunteers
Scientific title
Reduction of plasma glucose levels and improvement of plasma clinical biochemistry profiles in normal healthy volunteers after supplementation with Palm Fruit Juice
Secondary ID [1] 273251 0
NIL
Universal Trial Number (UTN)
U111-1125-3763
Trial acronym
PFJS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 279014 0
Hypercholesterolemia 279015 0
Condition category
Condition code
Diet and Nutrition 279200 279200 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each volunteer will be supplemented with 150 mL of the Palm Fruit Juice or placebo drinks, two times per day (morning and afternoon) for 60 days. A four-weeks of wash-out period is allowed between treatments.
Intervention code [1] 269590 0
Treatment: Other
Intervention code [2] 269614 0
Prevention
Comparator / control treatment
Placebo is made from mineral water with no sugar or preservative added. The placebo is bottled in an amber glass capped bottle.
Control group
Placebo

Outcomes
Primary outcome [1] 279835 0
Significant reduction in plasma glucose level. This will be assessed from the plasma analysis on the fasting blood samples of each volunteers.
Timepoint [1] 279835 0
60 days after supplementation
Secondary outcome [1] 294534 0
Improvement of any clinical biochemistry blood profiles. These profiles will be assessed from the plasma analysis on the fasting blood samples of each volunteers
Timepoint [1] 294534 0
60 days after supplementation

Eligibility
Key inclusion criteria
Healthy, normal levels of fasting TAG (<1.9 mmol/L) and fasting plasma glucose (<6.1 mmol/L), having good record of compliance.

"Having good record of compliance" means that the volunteers must consume the Palm Fruit Juice or placebo treatment everyday. They also need to report to the clinic on day 0, day 30 and day 60 for medical examination and bleeding session.
Minimum age
20 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking, habitual alcohol consumption, taking any types of drugs/pharmacological agent, herbs preparation, pregnant, lactating, on contraseptives, having any cardiovaskular diseases or cancer or any type of pathological conditions.

Study design
Purpose of the study
Prevention
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?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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] 3920 0
Malaysia
State/province [1] 3920 0
Selangor

Funding & Sponsors
Funding source category [1] 270078 0
Government body
Name [1] 270078 0
Malaysian Ministry of Agriculture & Agrobased industry
Address [1] 270078 0
Wisma Tani, No. 28 Persiaran Perdana, Presint 4, Pusat Pentadbiran Kerajaan Persekutuan, 62624 Putrajaya.
Country [1] 270078 0
Malaysia
Primary sponsor type
Government body
Name
Malaysian Ministry of Agriculture & Agrobased industry
Address
Wisma tani, No. 28 Persiaran Perdana, Presint 4, Pusat Pentadbiran Kerajaan Persekutuan, 62624 Putrajaya.
Country
Malaysia
Secondary sponsor category [1] 269045 0
Government body
Name [1] 269045 0
Malaysian Palm Oil Board
Address [1] 269045 0
6, Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor
Country [1] 269045 0
Malaysia
Other collaborator category [1] 252309 0
University
Name [1] 252309 0
National University of Malaysia/Universiti Kebangsaan Malaysia (UKM).
Address [1] 252309 0
Department of Pharmacology, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM), Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur.
Country [1] 252309 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272036 0
Medical Research and Ethics Committee, Malaysian Ministry of Health.
Ethics committee address [1] 272036 0
c/o Institute for Health Management, Jalan Rumah Sakit, Bangsar, 59000 Kuala Lumpur.
Ethics committee country [1] 272036 0
Malaysia
Date submitted for ethics approval [1] 272036 0
04/11/2009
Approval date [1] 272036 0
01/07/2011
Ethics approval number [1] 272036 0
NMRR-08-1618-3108

Summary
Brief summary
Preliminary studies discovered that supplementation of palm fruit juice (PFJ) manages to improve circulating blood glucose and plasma TG in Nile rats with early diabetes (mean glucose >110 mg/dL). Additionally, a long-term intake of PFJ protected healthy, young Nile rats against diabetes onset, as measured by glucose, blood lipids, and weight of livers and kidneys. These observations are probably due to the antioxidant protection by phenolics compound in the PFJ and their protection of beta-cells in the pancreatic islet against oxidative stress. Therefore, the beta-cells will be able to maintain its integrity and consistently produce insulin. In order to produce continuous and sufficient insulin for the body, the beta-cell must be protected against oxidation stress. Given that the PFJ contains several types of phenolics compounds, we hypothesize that supplementation of the PFJ may provide an antioxidant protection against oxidative stress in diabetic subject.

Currently, there is still no clinical data from human study on the physiological effects of PFJ. Moreover, the number of human study investigating the antioxidant potential of several common phenolics compounds such as quercetin and catechin is still limited. One of the goals in delaying the onset of type 2 DM is to preserve the function of beta-cells in the pancreatic islet. Based on the current evidence from the preliminary studies on palm PFJ, we hypothesize that supplementation of PFJ to humans at pre-diabetic state may prevent or delay the development of type 2 DM.

However, in order to understand the anti-diabetic effect of PFJ in humans, we need to firstly establish our knowledge on the physiological effects of this compound to normal human subjects. Under physiological condition, PFJ may improve the antioxidant status profiles of healthy subjects. In pre-diabetic subjects, improvement of antioxidant status may have a positive influence on plasma diabetes profiles, since many scientific evidences demonstrate that there is an inverse relationship between antioxidant status and incidence of DM. Therefore, we proposed a human nutrition study to evaluate the antioxidant effects of PFJ (which contained high concentration of palm phenolics compound) on healthy human subjects. Data from this study would hopefully assists us in understanding the therapeutical roles of palm phenolics on humans under normal conditions.

This study will involve the recruitment of healthy normal human volunteers. The study will be started with 25 healthy volunteers where they will be supplemented with PFJ or placebo drinks for a period of 60 days. Blood samples will be analyzed for several antioxidant status, lipid and diabetic profiles at baseline and after supplementation (on day-60).
Trial website
Trial related presentations / publications
1. Sambanthamurthi R, Tan Y, Sundram K, Abeywardena M, Sambandan TG, Rha C, Sinskey AJ, Subramaniam K, Leow SS, Hayes KC, Basri Wahid M. Oil palm vegetation liquor: a new source of phenolic bioactives. Br J Nutr. 2011 Jun 6:1-9. [Epub ahead of print].

2. Sambanthamurthi R, Tan Y, Sundram K, Hayes KC, Abeywardena M, Leow SS, Devi Sekaran S, Sambandan TG, Rha C, Sinskey AJ, Subramaniam K, Fairus S, Basri Wahid M. Positive outcomes of oil palm phenolics on degenerative diseases in animal models. Br J Nutr. 2011 Jun 7:1-12. [Epub ahead of print].
Public notes

Contacts
Principal investigator
Name 33294 0
Address 33294 0
Country 33294 0
Phone 33294 0
Fax 33294 0
Email 33294 0
Contact person for public queries
Name 16541 0
Dr Syed Fairus
Address 16541 0
Advanced Biotechnology & Breeding Centre (ABBC), Malaysian Palm Oil Board (MPOB), No. 6, Persiaran Institusi, Bandar Baru Bangi, 43000, Kajang, Selangor
Country 16541 0
Malaysia
Phone 16541 0
+603-87694604
Fax 16541 0
+603-89261995
Email 16541 0
syfairus@mpob.gov.my
Contact person for scientific queries
Name 7469 0
Dr Syed Fairus
Address 7469 0
Advanced Biotechnology & Breeding Centre (ABBC), Malaysian Palm Oil Board (MPOB), No. 6, Persiaran Institusi, Bandar Baru Bangi, 43000, Kajang, Selangor
Country 7469 0
Malaysia
Phone 7469 0
+603-87694604
Fax 7469 0
+603-89261995
Email 7469 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