Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000398505
Ethics application status
Approved
Date submitted
7/09/2006
Date registered
11/09/2006
Date last updated
11/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Modified Starch and Colon Health Study 2006
Scientific title
A phase 1-2 randomised double blind crossover study evaluating the efficacy of a patented modified high amylose starch to improve bowel health biomarkers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon health in healthy subjects 1364 0
Condition category
Condition code
Oral and Gastrointestinal 1457 1457 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 (2) modified starch, both at 2 dose rates (1) 20g per day (2) 40g per day. 4 x Intervention periods of 14 days each 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] 1350 0
Prevention
Comparator / control treatment
(1) control starch at 2 dose rates, 20g per day. 4 x Intervention periods of 14 days each with a 7 day 'wash out' at starch crossover.
Control group
Active

Outcomes
Primary outcome [1] 2009 0
To quantify release of SCFA's (short chain fatty acids) in the colon by way of measuring faecal SCFA's
Timepoint [1] 2009 0
At the beginning and end of each 14 day test period
Secondary outcome [1] 3482 0
Examine the corresponding changes to colonic microflora populations.
Timepoint [1] 3482 0
At the beginning and end of each 14 day test period.

Eligibility
Key inclusion criteria
1. Generally in good health 2. Be willing to consume a diet with controlled levels of fibre and carbohydrate during 11 weeks of the study period 3. Willing to comply with faecal sample collection requirements. 4. Available for the duration of the study (15 weeks from February 2006). 5. Have low (<15mmol/L) faecal butyrate concentrations.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Definite or suspected personal or family history of adverse events or hypersensitivity to wheat (eg celiac disease, wheat allergy)2. Use of 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 trial 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 independantly by central (non project) administration staff
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Subjects, clinical trial coordinnating staff and analytical staff are blinded to the treatment matrix
Phase
Phase 1 / Phase 2
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1594 0
Government body
Name [1] 1594 0
Commonwealth Scientific and Industrial Research Organisation Preventative Health Flagship
Country [1] 1594 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation Preventative Health Flagship
Address
Country
Australia
Secondary sponsor category [1] 1400 0
Government body
Name [1] 1400 0
Commonwealth Scientific and Industrial Research Organisation Human Nutrition
Address [1] 1400 0
Country [1] 1400 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3018 0
Commonwealth Scientific and Industrial Research Organisation Human Nutrition, Human Ethics Committee
Ethics committee address [1] 3018 0
Ethics committee country [1] 3018 0
Australia
Date submitted for ethics approval [1] 3018 0
Approval date [1] 3018 0
31/12/2005
Ethics approval number [1] 3018 0
05/23

Summary
Brief summary
The objective of this study is to determine whether bacteria in the colon of humans can release butyrate bound to starch. This will be investigated by feeding a modified test starch to volunteers and measuring butyrate levels in faeces, the effects on the bacteria and other bowel health indicators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27957 0
Address 27957 0
Country 27957 0
Phone 27957 0
Fax 27957 0
Email 27957 0
Contact person for public queries
Name 10539 0
Julie Clarke
Address 10539 0
CSIRO Human Nutrition
PO box 10041 Adelaide BC
SA 5000
Country 10539 0
Australia
Phone 10539 0
08 8303 8925
Fax 10539 0
Email 10539 0
[email protected]
Contact person for scientific queries
Name 1467 0
Peter Royle
Address 1467 0
CSIRO Human Nutrition
PO box 10041 Adelaide BC
SA 5000
Country 1467 0
Australia
Phone 1467 0
08 8303 8947
Fax 1467 0
Email 1467 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.