Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001263583
Ethics application status
Approved
Date submitted
9/11/2015
Date registered
19/11/2015
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can Phytochemicals Alter Intestinal Carbohydrate Digestion in Ileostomates
Scientific title
Phytochemicals and carbohydrate digestion in ileostomates as measured by ileal carbohydrate excretion
Secondary ID [1] 287831 0
none
Universal Trial Number (UTN)
U1111-1176-3349
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 296721 0
Condition category
Condition code
Diet and Nutrition 296953 296953 0 0
Obesity
Oral and Gastrointestinal 296954 296954 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will adhere to a low starch and sucrose dietary pattern for 4 days (Monday-Thursday) as set by the research dietitian; with the exception of a daily high starch/high sucrose breakfast test meal. Monday is a planned run in day and Wednesday a washout day. On Tuesday and Thursday participants will be randomised to consume one of two test drinks with the breakfast meal. Drinks are identical with the exception of one containing a phytonutrient rich sugar cane molasses extract, made up in water to a volume of 355mL. Dietary compliance is assessed by dietary records. Ileal efflux is collected at regular intervals (2 hourly; 07:00-23:00) for the duration of the study to measure carbohydrate excretion.
Intervention code [1] 293221 0
Prevention
Comparator / control treatment
No treatment control test day. Participants will consume a placebo beverage of 355mL water.
Control group
Active

Outcomes
Primary outcome [1] 296564 0
ileal carbohydrate excretion - AOAC official method 996.11; Prosky gravimetric technique
Timepoint [1] 296564 0
0-24 hrs post test meal/drink
Secondary outcome [1] 318758 0
none
Timepoint [1] 318758 0
none

Eligibility
Key inclusion criteria
minimal terminal ileum removed
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 a study within 30 days of commencement of the present study.
Use of any medication or supplement that may, in the opinion of the Principal Investigator, interfere with the study or small intestinal function.
Definite or suspected personal or family history of intolerance or adverse events following consumption of foods which may be tested in this study.
Person considered, in the opinion of the Principle Investigator, to be unwilling, unlikely or unable to comprehend or comply with the study protocol.
Unwilling or unable to collect ileal effluent as required.

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
Crossover
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/11/2015
Date of last participant enrolment
Anticipated
21/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 12196 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 292354 0
Commercial sector/Industry
Name [1] 292354 0
The Product Makers (TPM)
Country [1] 292354 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] 291033 0
None
Name [1] 291033 0
none
Address [1] 291033 0
none
Country [1] 291033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293818 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 293818 0
Ethics committee country [1] 293818 0
Australia
Date submitted for ethics approval [1] 293818 0
18/08/2015
Approval date [1] 293818 0
27/10/2015
Ethics approval number [1] 293818 0
10/2015

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

Contacts
Principal investigator
Name 55038 0
Dr Bianca Benassi-Evans
Address 55038 0
CSIRO Food and Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Country 55038 0
Australia
Phone 55038 0
+61 8 83038982
Fax 55038 0
Email 55038 0
[email protected]
Contact person for public queries
Name 55039 0
Bianca Benassi-Evans
Address 55039 0
CSIRO Food and Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Country 55039 0
Australia
Phone 55039 0
+61 8 83038982
Fax 55039 0
Email 55039 0
[email protected]
Contact person for scientific queries
Name 55040 0
Tony Bird
Address 55040 0
CSIRO Food and Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Country 55040 0
Australia
Phone 55040 0
+61 8 83038902
Fax 55040 0
Email 55040 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.