Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000746033
Ethics application status
Approved
Date submitted
3/09/2010
Date registered
7/09/2010
Date last updated
7/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the resistant starch content of new barley varieties prepared as muffin bars in volunteers with ileostomy.
Scientific title
Determing the resistant starch content of new barley varieties prepared as muffin bars in volunteers with ileostomy.
Secondary ID [1] 252628 0
no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Development of an assay that predicts resistant starch in new cereals by relating in vitro and in vivo determinations. 258126 0
Condition category
Condition code
Diet and Nutrition 258302 258302 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 258315 258315 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are four treatments (three test foods and one control) to be consumed by participants as well as the specified breakfast each day on four consecutive days.
Throughout the trial period (four consecutive days) participants consume a basal diet which contains specially selected foods known to be low in resistant starch content. Since the participants are required to consume the same restricted basal diet for four consecutive days all foods are provided by the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The participants are free to select their basal diet from a list of suitable foods provided by CSIRO and the these foods are required to be eaten at the same times each day of the four day trial period.
On top of these basal diets the participants will consume a muffin bar (one bar for each day and ~50g per bar) prepared from each of the three test flours under investigation. One day will be a control day in which the participants will consume only the basal diet (no muffin bar).
The study is a randomised crossover design where each participant consumes each of the test muffin bars and has a control day in the four day trial period. A test day spans a 24 hr period from the consumption of breakfast at 7.30 am one day to the final ileal digesta collection taken at ~7am the following day.
On the first day of the study the participants empty their stomal bags at 7 am (this sample is discarded) and then collect and freeze digesta samples every 2 hrs until 11pm. Their final collection for day 1 is at 7 am on day 2. this pattern of digesta collection continues until the final collection at 7 am on day 5 at which point the trial is complete. There are 9 digesta samples in each test period and they are frozen immediately after collection and remain frozen until analysed.
Intervention code [1] 257152 0
Treatment: Other
Comparator / control treatment
Control is a low starch diet only with very little resistant starch(< 0.5g /day. This is made possible by participants selecting their daily food from a list of foods that are known to contain minimal resistant starch and CSIRO providing all the foods for the trial period to each participant.
As this is a crossover designed study each participant acts as their own control
Control group
Active

Outcomes
Primary outcome [1] 259149 0
Determination of the starch in the various muffin bars (and therefore the test flours) that is resistant to digestion.
Timepoint [1] 259149 0
Ileal samples collected at 7am on day 1 and there after at 2 hr intervals until 11 pm at night. This collection pattern is repeated on each of the 4 days in the trial period ie a total of 9 collections for each day from Monday 7 am to Friday 7 am.
Secondary outcome [1] 265476 0
comparison of the in vivo resistant starch determination with the in vitro resistant starch (RS) determination on the same food products
Timepoint [1] 265476 0
Ileal samples collected at 7am on day 1 and there after at 2 hr intervals until 11 pm at night. This collection pattern is repeated on each of the 4 days in the trial period ie a total of 9 collections for each day from Monday 7 am to Friday 7 am.

Eligibility
Key inclusion criteria
conventional and well-functioning permanent ileostomy
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of any form of drug therapy or medication or supplements that may interfere with bowel function eg antibiotics.
Definite or suspected personal history or family history of adverse events or intolerance of plant-based foods being tested in this study
persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions
Persons unwilling or unable to collect ileal effluent as required
Participants taking any supplements which could interfere with study parameters

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)
Subject were enrolled from a pool of volunteers who have well functioning, permanent ileostomy and who have expressed an interest on participating in such studies on presious occasions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatments for each day are prepared by drawing each of the four test foods from a box for each volunteer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/09/2010
Actual
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)

Funding & Sponsors
Funding source category [1] 257594 0
Government body
Name [1] 257594 0
Food Futures National Research Flagship- Cereal and metabolic health stream
Country [1] 257594 0
Australia
Primary sponsor type
Government body
Name
National Research Flagship- Cereal and metabolic health stream
Address
CSIRO Food and Nutritional Sciences
PO Box 10041
BC Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 256822 0
None
Name [1] 256822 0
Address [1] 256822 0
Country [1] 256822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259616 0
CSIRO Food and Nutritional Sciences Human Ethics Committee
Ethics committee address [1] 259616 0
Ethics committee country [1] 259616 0
Australia
Date submitted for ethics approval [1] 259616 0
Approval date [1] 259616 0
01/04/2010
Ethics approval number [1] 259616 0

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

Contacts
Principal investigator
Name 31603 0
Address 31603 0
Country 31603 0
Phone 31603 0
Fax 31603 0
Email 31603 0
Contact person for public queries
Name 14850 0
Dr Tony Bird
Address 14850 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC
SA 5000
Country 14850 0
Australia
Phone 14850 0
+61 8 8303 8902
Fax 14850 0
Email 14850 0
[email protected]
Contact person for scientific queries
Name 5778 0
Dr Tony Bird
Address 5778 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC
SA 5000
Country 5778 0
Australia
Phone 5778 0
+61 8 8303 8902
Fax 5778 0
Email 5778 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.