Trial Review

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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
Scientific title
Dietary Fibre and Fat Absorption in Ileostomates as Measured by Ileal Fat Excretion
Secondary ID [1] 286199 0
nil
Universal Trial Number (UTN)
U1111-1167-3344
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dietary fat absorption 294235 0
Condition category
Condition code
Diet and Nutrition 294553 294553 0 0
Obesity
Oral and Gastrointestinal 295001 295001 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291218 0
Prevention
Comparator / control treatment
no treatment control test day
Control group
Active

Outcomes
Primary outcome [1] 294335 0
Ileal fat excretion - chloroform/methanol extraction gravimetric method
Timepoint [1] 294335 0
0-24 hours post test meal
Secondary outcome [1] 313066 0
nil
Timepoint [1] 313066 0
nil

Eligibility
Key inclusion criteria
Minimal terminal ileum removed.
Willing to comply with diet and alcohol restrictions.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation 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
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2015
Actual
5/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290773 0
Commercial sector/Industry
Name [1] 290773 0
Lion Dairy & Drinks Pty Ltd
Country [1] 290773 0
Australia
Primary sponsor type
Government body
Name
CSIRO Food and Nutrition
Address
Gate 13 Kintore Ave
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 289743 0
None
Name [1] 289743 0
Address [1] 289743 0
Country [1] 289743 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292407 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 292407 0
PO Box 10041
Adelaide SA 5000
Ethics committee country [1] 292407 0
Australia
Date submitted for ethics approval [1] 292407 0
16/02/2015
Approval date [1] 292407 0
16/02/2015
Ethics approval number [1] 292407 0
15/2014

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55042 0
Dr Tony Bird
Address 55042 0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Country 55042 0
Australia
Phone 55042 0
+61 08 83038902
Fax 55042 0
Email 55042 0
[email protected]
Contact person for public queries
Name 55043 0
Dr Bianca Benassi-Evans
Address 55043 0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Country 55043 0
Australia
Phone 55043 0
+61 08 83038982
Fax 55043 0
Email 55043 0
[email protected]
Contact person for scientific queries
Name 55044 0
Dr Tony Bird
Address 55044 0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Country 55044 0
Australia
Phone 55044 0
+61 08 83038902
Fax 55044 0
Email 55044 0
[email protected]

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

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