Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12615000343505
Ethics application status
Approved
Date submitted
11/03/2015
Date registered
15/04/2015
Date last updated
10/06/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Can Dietary Fibre Consumption Alter Fat Absorption in Ileostomates
Query!
Scientific title
Dietary Fibre and Fat Absorption in Ileostomates as Measured by Ileal Fat Excretion
Query!
Secondary ID [1]
286199
0
nil
Query!
Universal Trial Number (UTN)
U1111-1167-3344
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
dietary fat absorption
294235
0
Query!
Condition category
Condition code
Diet and Nutrition
294553
294553
0
0
Query!
Obesity
Query!
Oral and Gastrointestinal
295001
295001
0
0
Query!
Normal oral and gastrointestinal development and function
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The study is a randomised 2x2 factorial design with a high/low fibre beverage consumed with a high (65%)/moderate (40%) fat breakfast test meal. Participants will maintain a typical 'western diet' (total fat providing 30% of daily Energy) for the duration of the intervention. Participants will consume each of the 4 test meals over a two week period to allow for adequate washout period (4 days)between test meals. Dietary compliance will be assessed by dietary records. Ileal efflux is collected at regular intervals (2 hours) for the duration of the study to measure fat excretion.
Query!
Intervention code [1]
291218
0
Prevention
Query!
Comparator / control treatment
no treatment control test day
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
294335
0
Ileal fat excretion - chloroform/methanol extraction gravimetric method
Query!
Assessment method [1]
294335
0
Query!
Timepoint [1]
294335
0
0-24 hours post test meal
Query!
Secondary outcome [1]
313066
0
nil
Query!
Assessment method [1]
313066
0
Query!
Timepoint [1]
313066
0
nil
Query!
Eligibility
Key inclusion criteria
Minimal terminal ileum removed.
Willing to comply with diet and alcohol restrictions.
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
History of drug or alcohol abuse.
Participation in any other study within 30 days of commencement of the current study.
Any gastrointestinal, renal, hepatic disease or intestinal inflammation.
Use of any medication which in the opinion of the investigator could interfere with the study or modify small intestinal function.
use of any supplements that contain lipids or dietary fibres which could interfere with the study parameters.
Defined or suspected intolerance to the test foods.
Person considered unwilling, unlikely or unable to comply with the study protocol and restrictions.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by computer software
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Factorial
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Recruitment of 6 participants will give 80% power to detect a 2.5 fold difference in ileal fat excretion. Withdrawal rate in these interventions is low to nil so there will be a maximum recruitment of 8 participants required.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
27/04/2015
Query!
Actual
5/05/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
8
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Funding & Sponsors
Funding source category [1]
290773
0
Commercial sector/Industry
Query!
Name [1]
290773
0
Lion Dairy & Drinks Pty Ltd
Query!
Address [1]
290773
0
737 Bourke St
Docklands VIC 3008
Query!
Country [1]
290773
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
CSIRO Food and Nutrition
Query!
Address
Gate 13 Kintore Ave
Adelaide SA 5000
Query!
Country
Australia
Query!
Secondary sponsor category [1]
289743
0
None
Query!
Name [1]
289743
0
Query!
Address [1]
289743
0
Query!
Country [1]
289743
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
292407
0
CSIRO Human Research Ethics Committee
Query!
Ethics committee address [1]
292407
0
PO Box 10041 Adelaide SA 5000
Query!
Ethics committee country [1]
292407
0
Australia
Query!
Date submitted for ethics approval [1]
292407
0
16/02/2015
Query!
Approval date [1]
292407
0
16/02/2015
Query!
Ethics approval number [1]
292407
0
15/2014
Query!
Summary
Brief summary
This study aims to quantify whether the co-consumption of a high fibre beverage can alter dietary fat absorption of a high fat breakfast meal in ileostomates.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
55042
0
Dr Tony Bird
Query!
Address
55042
0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Query!
Country
55042
0
Australia
Query!
Phone
55042
0
+61 08 83038902
Query!
Fax
55042
0
Query!
Email
55042
0
[email protected]
Query!
Contact person for public queries
Name
55043
0
Bianca Benassi-Evans
Query!
Address
55043
0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Query!
Country
55043
0
Australia
Query!
Phone
55043
0
+61 08 83038982
Query!
Fax
55043
0
Query!
Email
55043
0
[email protected]
Query!
Contact person for scientific queries
Name
55044
0
Tony Bird
Query!
Address
55044
0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Query!
Country
55044
0
Australia
Query!
Phone
55044
0
+61 08 83038902
Query!
Fax
55044
0
Query!
Email
55044
0
[email protected]
Query!
No information has been provided regarding IPD availability
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.
Download to PDF