Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001442190
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
17/10/2019
Date last updated
17/10/2019
Date data sharing statement initially provided
17/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the health beneficial properties of coloured rice consumption in healthy populations
Scientific title
The bioavailability, antioxidant and anti-inflammatory properties of coloured rice consumption in healthy populations
Secondary ID [1] 299387 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular health (inflammation & oxidative stress biomarkers) 314564 0
Condition category
Condition code
Diet and Nutrition 312901 312901 0 0
Other diet and nutrition disorders
Cardiovascular 313189 313189 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Participants in a fasting state (minimum 8 hours, no food, water only) will be prepared for cannulation. The participants are either called or text messaged to remind them of their study fasting requirements. An intravenous cannula will be inserted into the arm vein using standard cannulation procedures (Guideline for PIVC Insertion and Post Insertion Care in Adult Patients, NSW Health) by a trained phlebotomist.
2. Baseline blood samples (25 mL) will be obtained and the participants will consume a serving of plain cooked coloured rice (one cup or 200 g) and have 20-minutes to consume the rice serving.
3. After rice consumption, blood samples (25 mL at each time point) will be taken at regular time intervals 0.5, 1, 2 ,4 ,6 hours post rice consumption.
4. The cannula will be removed and the site covered with sterile gauze.
5. A one week of wash out between cross over 2 (week 2 - day 7) and 3 (week 3 - day 14) will be applied. The order of rice varieties (black, red and brown rice) served to the participants is randomised for each participant over the 3 weeks (e.g. Participant 1 - Purple, brown, red; Participant 2 - red, purple brown). This randomisation is completed using Microsoft Office Excel.
Intervention code [1] 315647 0
Treatment: Other
Comparator / control treatment
Brown rice will be used as the control intervention
Control group
Active

Outcomes
Primary outcome [1] 321502 0
Cell adhesion molecules (ICAM, VCAM) levels assessed by ELISA of plasma. This is a composite primary outcome.
Timepoint [1] 321502 0
Acute intervention dietary trial
Week 1 - Coloured rice 1 (black, red or brown depending on randomisation assignment) - same day
Week 2 - Coloured rice 2 (black, red or brown depending on randomisation assignment) - same day
Week 3 - Coloured rice 3 (black, red or brown depending on randomisation assignment) - same day
Blood samples will be collected at 0.5, 1, 2 ,4 hours post rice consumption (during each intervention bout).
Primary outcome [2] 321503 0
Exploratory examination of oxidative stress biomarkers (SOD-1) as assessed by ELISA of plasma.
Timepoint [2] 321503 0
Acute intervention dietary trial
Week 1 - Coloured rice 1 (black, red or brown depending on randomisation assignment) - same day
Week 2 - Coloured rice 2 (black, red or brown depending on randomisation assignment) - same day
Week 3 - Coloured rice 3 (black, red or brown depending on randomisation assignment) - same day
Blood samples will be collected at 0.5, 1, 2 ,4 hours post rice consumption (during each intervention bout).
Primary outcome [3] 321504 0
Inflammatory biomarkers (IL-6, IL-8) antibody capture bead kit performed on plasma samples and obtained via flowcytometric methods. This is a composite primary outcome. as the kit can quantify multiple cytokines with the one plasma sample.
Timepoint [3] 321504 0
Acute intervention dietary trial
Week 1 - Coloured rice 1 (black, red or brown depending on randomisation assignment) - same day
Week 2 - Coloured rice 2 (black, red or brown depending on randomisation assignment) - same day
Week 3 - Coloured rice 3 (black, red or brown depending on randomisation assignment) - same day
Blood samples will be collected at 0.5, 1, 2 ,4 hours post rice consumption (during each intervention bout)
Secondary outcome [1] 375150 0
Not Applicable
Timepoint [1] 375150 0
Not Applicable

Eligibility
Key inclusion criteria
• Healthy (BMI 18.5 - 24.9 )
• Non-smoker
• Caucasian
• Male or Female (18 - 65 years)
• No current or medical history of Chronic diseases
• Non-pregnant
• Not currently taking anti-inflammatory, anti-dyslipidaemic or anti-clotting medications
• No known problems with venepuncture
• Not currently taking multivitamin supplements
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum sample size of 21 volunteers is required for 80% power to detect a 5% variation in the laboratory parameters measured, where a 3–5% standard deviation exists in the population, assuming an alpha error of 0.05.
Graph Pad Prism statistical analysis software will be used to evaluate the impact of the acute intervention of coloured rice. Analysis of variance (ANOVA) coupled with post-hoc analysis will be employed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2019
Date of last participant enrolment
Anticipated
Actual
28/02/2019
Date of last data collection
Anticipated
Actual
28/06/2019
Sample size
Target
22
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303899 0
Government body
Name [1] 303899 0
Australian Research Council
Country [1] 303899 0
Australia
Primary sponsor type
Individual
Name
Dr. Abishek Santhakumar
Address
Charles Sturt University, School of Biomedical Sciences
Locked Bag 588, Bldg 288, Room 238
Wagga Wagga, NSW 2678
Country
Australia
Secondary sponsor category [1] 304047 0
Individual
Name [1] 304047 0
Prof Christopher Blanchard
Address [1] 304047 0
Charles Sturt University, School of Biomedical Sciences
Locked Bag 588, Bldg 288, Room 226
Wagga Wagga, NSW 2678
Country [1] 304047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304405 0
Charles Sturt University Human Research Ethics Committee [EC00116]
Ethics committee address [1] 304405 0
Ethics committee country [1] 304405 0
Australia
Date submitted for ethics approval [1] 304405 0
10/09/2018
Approval date [1] 304405 0
17/09/2018
Ethics approval number [1] 304405 0
H18065

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

Contacts
Principal investigator
Name 96834 0
Dr Abishek Santhakumar
Address 96834 0
Charles Sturt University, Locked Bag 588, Bldg 288, Room 238
Wagga Wagga, NSW 2678,
Country 96834 0
Australia
Phone 96834 0
+61269332678
Fax 96834 0
Email 96834 0
[email protected]
Contact person for public queries
Name 96835 0
Esther Callcott
Address 96835 0
Charles Sturt University, School of Biomedical Sciences
Locked Bag 588, Bldg 289, Room 2006,
Wagga Wagga, NSW 2678
Country 96835 0
Australia
Phone 96835 0
+61269332927
Fax 96835 0
Email 96835 0
[email protected]
Contact person for scientific queries
Name 96836 0
Abishek Santhakumar
Address 96836 0
Charles Sturt University, Locked Bag 588, Bldg 288, Room 238
Wagga Wagga, NSW 2678,
Country 96836 0
Australia
Phone 96836 0
+61269332678
Fax 96836 0
Email 96836 0
[email protected]

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 Supporting Document Provided



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.