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Trial registered on ANZCTR


Registration number
ACTRN12610000010099
Ethics application status
Approved
Date submitted
5/01/2010
Date registered
6/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Acetylated Starch on Colon Health 2009
Scientific title
A phase 1-2 randomised double blind crossover study evaluating the efficacy of acetylated high amylose starch on bowel health biomarkers in healthy volunteers
Secondary ID [1] 1238 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon health in healthy subjects 252086 0
Condition category
Condition code
Oral and Gastrointestinal 252292 252292 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 x 4 double blind crossover study examining 2 starches (1) control starch at 2 dose rates (a) 20g per day, (b) 40g per day and (2) modified starch at 2 dose rates (a) 20g per day, (b) 40g per day. Beginning with 14 days on low resistant starch diet then 4 x Intervention periods of 14 days with a 7 day 'wash out' at starch crossover. Both starches to be ingested orally by way of combination (starch plus long life milk)
Intervention code [1] 241477 0
Prevention
Comparator / control treatment
(1) control starch (high amylose maize starch) at 2 dose rates, 20g or 40g per day for 14 days.
Control group
Active

Outcomes
Primary outcome [1] 257452 0
To quantify the release of short chain fatty acids (SCFAs) in the colon. SCFA concentrations in faecal samples will be analysed using stndard distillation procedures and gas chromatography.
Timepoint [1] 257452 0
At the beginning and end of each 14 day test period
Primary outcome [2] 257546 0
To examine changes to electrolyte levels. Venous blood samples will be collected into gel tubes to test for changes in the levels of electrolytes using biochemical analysis.
Timepoint [2] 257546 0
At the beginning and end of each 14 day test period
Secondary outcome [1] 262603 0
To examine changes in colonic microflora populations and bowel function in faecal samples. Faecal sample measures include faecal bulk, pH, moisture and microflora profiles.
Timepoint [1] 262603 0
At the beginning and end of each 14 day test period

Eligibility
Key inclusion criteria
1. Male or Female 2. Generally in good health 3. Be willing to consume a diet with controlled levels of fibre and carbohydrate during 15 weeks of the study period 4. Willing to comply with blood and faecal sample collection requirements 5. Available for the duration of the study 6. Have low-average faecal acetate levels
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Definite or suspected personal family history of adverse events or hypersensitivity to wheat (eg coeliac disease, wheat allergy). 2. Use any form of drug therapy or medication or supplements on a regular basis that may interfere with bowel function (eg laxatives, antibiotics, anti-diarrhoeals or probiotics). 3. Consuming any prescribed or over-the-counter medication that in the opinion of the investigator could interfere with the study (eg Codeine, Panadeine, Nucolox, Metamucil, Sennocot). 4. Participation in a bowel health study or in any study of an experimental drug within 30 days of commencement of this study. 5. History or presence of gastrointestinal, renal or hepatic disease of any cause. 6. Reported lactating, pregnant or wish to become pregnant during the study. If the volunteer becomes pregnant during the study they will be withdrawn. 7. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment by allocation schedule held independently by central administration staff
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256239 0
Government body
Name [1] 256239 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health Flagship
Address [1] 256239 0
PO Box 10041 Adelaide BC SA 5000
Country [1] 256239 0
Australia
Primary sponsor type
Government body
Name
CSIRO Preventative Health Flagship
Address
Kintore Avenue Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 251583 0
None
Name [1] 251583 0
Address [1] 251583 0
Country [1] 251583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258330 0
Commonwealth Scientific Industrial Research Organisation Human Nutrition, Human Research Ethics Committee
Ethics committee address [1] 258330 0
PO Box 10041 Adelaide BC SA 5000
Ethics committee country [1] 258330 0
Australia
Date submitted for ethics approval [1] 258330 0
Approval date [1] 258330 0
03/06/2009
Ethics approval number [1] 258330 0
9/12/2010

Summary
Brief summary
The objective of this study is to determine whether ingested acetate which has been chemically attached to starch is released in the gastrointestinal tract of healthy humans. This will be determined by feeding known amounts of a high amylose maize starch to volunteers and measuring acetate levels in faeces, microbial population diversity, bowel health parameters, and blood electrolyte levels. This study will provide information about the effects and acceptability of the acetylated starch in healthy individuals and will provide the basis for clinical studies in patients with diarrhoeal disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30439 0
Address 30439 0
Country 30439 0
Phone 30439 0
Fax 30439 0
Email 30439 0
Contact person for public queries
Name 13686 0
Jessica Winkler
Address 13686 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC SA 5000
Country 13686 0
Australia
Phone 13686 0
+61 8 8303 8927
Fax 13686 0
Email 13686 0
jessica.winkler@csiro.au
Contact person for scientific queries
Name 4614 0
Julie Clarke
Address 4614 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC SA 5000
Country 4614 0
Australia
Phone 4614 0
+61 8 8303 8925
Fax 4614 0
Email 4614 0
julie.clarke@csiro.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary