Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001006235
Ethics application status
Approved
Date submitted
12/06/2018
Date registered
14/06/2018
Date last updated
27/05/2019
Date data sharing statement initially provided
27/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the health beneficial properties of coloured rice consumption in obese populations.
Scientific title
The bioavailability, antioxidant and anti-inflammatory properties of coloured rice consumption in obese populations.
Secondary ID [1] 295180 0
None
Universal Trial Number (UTN)
Trial acronym
CROPS - Coloured rice obesity polyphenol study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 308310 0
Condition category
Condition code
Diet and Nutrition 307312 307312 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Participants in a fasting state (minimum 8 hours) will be prepared for cannulation. 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) in week 1 (day 1) - black, red or brown rice (randomised)
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. One week of wash out between cross over 2 (week 2 - day 7) and 3 (week 3 - day 14) will be applied.
Intervention code [1] 301517 0
Treatment: Other
Comparator / control treatment
Brown rice will be used as the control intervention
Control group
Active

Outcomes
Primary outcome [1] 306270 0
Cell adhesion molecules (ICAM, VCAM) levels assessed using ELISA
Timepoint [1] 306270 0
Acute intervention dietary trial
Week 1 - Coloured rice 1 (black) - same day
Week 2 - Coloured rice 2 (red) - same day
Week 3 - Coloured rice 3 (brown) - same day
Blood samples will be collected at 0.5, 1, 2 ,4 hours post rice consumption (during each intervention bout).
Primary outcome [2] 306312 0
Exploratory examination of oxidative stress biomarkers (SOD-1) as assessed by ELISA
Timepoint [2] 306312 0
Acute intervention dietary trial
Week 1 - Coloured rice 1 (black) - same day
Week 2 - Coloured rice 2 (red) - same day
Week 3 - Coloured rice 3 (brown) - same day
Blood samples will be collected at 0.5, 1, 2 ,4 hours post rice consumption (during each intervention bout).
Primary outcome [3] 306313 0
Inflammatory biomarkers (IL-6, IL-8) assessed by flowcytometry
Timepoint [3] 306313 0
Acute intervention dietary trial
Week 1 - Coloured rice 1 (black) - same day
Week 2 - Coloured rice 2 (red) - same day
Week 3 - Coloured rice 3 (brown) - same day
Blood samples will be collected at 0.5, 1, 2 ,4 hours post rice consumption (during each intervention bout).
Secondary outcome [1] 348031 0
Not applicable
Timepoint [1] 348031 0
Not applicable

Eligibility
Key inclusion criteria
• Obese (BMI> 30)
• Non-smoker
• Caucasian
• Performs less than 3hrs exercise per week
• 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?
No
Key exclusion criteria
• Normal BMI
• Smoker
• Non-Caucasian
• Performs more than 3hrs exercise per week
• Male or Female (less than 18 years or greater than 65 years of age)
• Currently suffering from chronic disorders
• Pregnant
• Currently taking anti-inflammatory, anti-dyslipidaemic, anti-clotting medications or multivitamin supplementations

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
4/06/2018
Date of last participant enrolment
Anticipated
30/06/2018
Actual
30/06/2018
Date of last data collection
Anticipated
30/08/2018
Actual
20/11/2018
Sample size
Target
22
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299765 0
Government body
Name [1] 299765 0
Australian Research Council
Country [1] 299765 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] 299107 0
Individual
Name [1] 299107 0
Prof Christopher Blanchard
Address [1] 299107 0
Charles Sturt University, School of Biomedical Sciences
Locked Bag 588, Bldg 288, Room 226
Wagga Wagga, NSW 2678
Country [1] 299107 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300656 0
Charles Sturt University Human Research Ethics Committee [EC00116]
Ethics committee address [1] 300656 0
Ethics committee country [1] 300656 0
Australia
Date submitted for ethics approval [1] 300656 0
Approval date [1] 300656 0
03/05/2018
Ethics approval number [1] 300656 0
H18065

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

Contacts
Principal investigator
Name 84362 0
Dr Abishek Santhakumar
Address 84362 0
Charles Sturt University, Locked Bag 588, Bldg 288, Room 238
Wagga Wagga, NSW 2678,
Country 84362 0
Australia
Phone 84362 0
+61269332678
Fax 84362 0
Email 84362 0
[email protected]
Contact person for public queries
Name 84363 0
Esther Callcott
Address 84363 0
Charles Sturt University, School of Biomedical Sciences
Locked Bag 588, Bldg 289, Room 2006,
Wagga Wagga, NSW 2678
Country 84363 0
Australia
Phone 84363 0
+61 2 6933 2927
Fax 84363 0
Email 84363 0
[email protected]
Contact person for scientific queries
Name 84364 0
Abishek Santhakumar
Address 84364 0
Charles Sturt University, Locked Bag 588, Bldg 288, Room 238
Wagga Wagga, NSW 2678,
Country 84364 0
Australia
Phone 84364 0
+61269332678
Fax 84364 0
Email 84364 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.