Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000947202
Ethics application status
Approved
Date submitted
3/11/2009
Date registered
4/11/2009
Date last updated
4/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The potential of food processing technologies to improve bioavailability of carotenoids from carrots-a pilot study in volunteers with ileostomy
Scientific title
The potential of food processing technologies to improve bioavailability of carotenoids from carrots-a pilot study in volunteers with ileostomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bioavailability of phytochemicals, in particular carotenoids from foods (carrots) of varying but controlled particle size 252094 0
Condition category
Condition code
Diet and Nutrition 252301 252301 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants consume a basal diet low in natural carotenoids throughout the 4 days trial period of each week( Monday to Thursday) and on test days consume one of the 4 test foods (carrot soup). There are 2 control days and 2 test food days on 2 consecutive weeks
Participants are required to follow the low carotenoid basal diet for a period of 4 days each week for 2 consecutive weeks.
This diet is supplied by CSIRO from specially selected foods to restrict the intake of carotenoid containing foods such as carrots, oranges and tomatoes to a daily dose of <650ug.
For each of the test foods the participants will be required to eat a single 300mL serve of the carrot soup containing ~15 mg carotenoids along with 2 slices of white bread and 10g of butter.
There will be a 3 day wash-out period between trial periods (from Friday one week to Monday the following week).
In each week each participant would randomly have 2 of the test foods on any of the 4 days within that week. The remaining 2 days are control days during which the participants consume only the basal diet with low carotenoids as supplied by CSIRO. During the following week the participants would be required to have the remaining 2 test foods on randomly selected days with the 2 remaining days being control days as described above.
Intervention code [1] 241489 0
Treatment: Other
Comparator / control treatment
Control is a low carotenoid diet only with no carrot soup administered by CSIRO supplying all the foods to participants for each of the 4 days trial periods. The diets have been selected to contain < 650ug carotenoids per day
Control group
Active

Outcomes
Primary outcome [1] 253175 0
determination of the % of carotenoids absorbed by mass calculation
Timepoint [1] 253175 0
ileal samples collected at 7am on day 1 of each trial period and there after at 2 hr intervals until ~11pm at night. This pattern is replicated for the 4 days of each trial period ie a total of 9 collections for each day from Monday 7am to Friday 7am for each of 2 weeks
Secondary outcome [1] 262097 0
microscopy of ileal digesta
Timepoint [1] 262097 0
ileal samples collected at 7am on day 1 of each trial period and there after at 2 hr intervals until ~11pm at night. This pattern is replicated for the 4 days of each trial period ie a total of 9 collections for each day from Monday 7am to Friday 7am for each of 2 weeks
Secondary outcome [2] 262113 0
Time course of carrot digestion and flow to the ileal collection
Timepoint [2] 262113 0
ileal samples collected at 7am on day 1 of each trial period and there after at 2 hr intervals until ~11pm at night. This pattern is replicated for the 4 days of each trial period ie a total of 9 collections for each day from Monday 7am to Friday 7am for each of 2 weeks

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 withthe study protocol and restrictions
Persons unwilling or unable to collect ileal effluent as required
Paticipants 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)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (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
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/11/2009
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] 243955 0
Government body
Name [1] 243955 0
Food Futures Flagship- Nutrient release and Bioavailability Stream
Country [1] 243955 0
Australia
Primary sponsor type
Government body
Name
Food Futures Flagship- Nutrient release and Bioavailability Stream
Address
PO Box 10041
BC Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 251311 0
Government body
Name [1] 251311 0
CSIRO Food and Nutritional Sciences
Address [1] 251311 0
PO Box 10041
BC Adelaide
SA 5000
Country [1] 251311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244068 0
CSIRO Food Sciences and Nutrition Adelaide
Ethics committee address [1] 244068 0
PO Box 10041
Adelaide BC
SA 5000
Ethics committee country [1] 244068 0
Australia
Date submitted for ethics approval [1] 244068 0
Approval date [1] 244068 0
Ethics approval number [1] 244068 0

Summary
Brief summary
The up-take (bio-availability) of carotenoids is not well understood and conventional methods (plasma anlayses) of determining up take is open to interpretation errors. This pilot study is aimed at assessing the ileostomy model as a model for estimation of bioavailability of nutrients from plant based foods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30447 0
Address 30447 0
Country 30447 0
Phone 30447 0
Fax 30447 0
Email 30447 0
Contact person for public queries
Name 13694 0
Dr Tony Bird
Address 13694 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC
SA 5000
Country 13694 0
Australia
Phone 13694 0
+61 8 8303 8902
Fax 13694 0
Email 13694 0
tony.bird@csiro.au
Contact person for scientific queries
Name 4622 0
Dr Tony Bird
Address 4622 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC
SA 5000
Country 4622 0
Australia
Phone 4622 0
+61 8 8303 8902
Fax 4622 0
Email 4622 0
tony.bird@csiro.au

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
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