Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000211965
Ethics application status
Approved
Date submitted
24/02/2011
Date registered
25/02/2011
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Determination of the digestive health benefits of new barley breakfast cereals.
Scientific title
Determination of the digestive health benefits of new barley breakfast cereals in healthy male and female adults.
Secondary ID [1] 259670 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal bowel health and function 261240 0
Condition category
Condition code
Diet and Nutrition 259385 259385 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 259386 259386 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will be testing 4 different breakfast cereals, a conventional barley cereal, 2 new barley cereals and a refined cereal. Barley cereals are derived from Barley lines that differ in nutrient composition. Participants will consume each of the 4 test foods in 4 week blocks, with each test food period to be separated by 2 weeks. For the duration of the study participants will be required to consume their usual diet with some restrictions to ensure it is low in fibre. For each 4 week test period, they will be required to consume 50g of the test food daily. At the beginning of the study and at the end of each 4 week testing period participants will be required to attend the Clinic for a 15 minute appointment to discuss digestive health and prior to the visit collect a 48 hour faecal and urine collection and 3 short questionnaires (product consumption checklist, 3-day food diary and physical activity questionnaire). At baseline only, they will be required to undergo a whole body and forearm DEXA scan.
Intervention code [1] 258100 0
Prevention
Intervention code [2] 258107 0
Lifestyle
Comparator / control treatment
refined cereal
Control group
Active

Outcomes
Primary outcome [1] 262204 0
Bowel function:
participant self-report - bowel habits
laboratory analysis - faecal pH, fermentation profile
Timepoint [1] 262204 0
Baseline and after each 4 week test food period
Secondary outcome [1] 273324 0
Digestive comfort questionnaire
Timepoint [1] 273324 0
Baseline and after each 4 week test food period
Secondary outcome [2] 279262 0
Mineral balance: urine laboratory analysis
Timepoint [2] 279262 0
baseline and after each 4 week test food period
Secondary outcome [3] 279263 0
Dual Energy Xray Absorptiometry scan for body composition and bone mineral density
Timepoint [3] 279263 0
baseline

Eligibility
Key inclusion criteria
Male or female, aged 20-80 years.
BMI 19-25.
Not received any medication that in the opinion of the investigator could interfere with the study and no medications likely to modulate gut function.
No history of alcohol or drug abuse.
No participation in a study with any experimental drug within 30 days of commencement of the study.
No presence of gastrointestinal, renal, hepatic disease or intestinal inflammation.
Willing to comply with study diet and alcohol restrictions.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of any form of drug therapy or medication or supplements that may interfere with bowel function (such as antibiotics, laxatives etc).
Known or suspected personal history or family history of adverse events, hypersensitivity or intolerance to consumption plant-based foods which will be tested in this study.
Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
Unwilling or unable to collect bowel motions as required.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258560 0
Government body
Name [1] 258560 0
CSIRO Food Futures National Research Flagship
Country [1] 258560 0
Australia
Primary sponsor type
Government body
Name
CSIRO Food Futures National Research Flagship
Address
CSIRO Food and Nutritional Sciences
PO Box 10041
BC Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 257699 0
None
Name [1] 257699 0
Address [1] 257699 0
Country [1] 257699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260535 0
CFNS Human Research Ethics Committee
Ethics committee address [1] 260535 0
PO Box 10041
Adelaide BC
SA 5000
Ethics committee country [1] 260535 0
Australia
Date submitted for ethics approval [1] 260535 0
Approval date [1] 260535 0
17/09/2010
Ethics approval number [1] 260535 0
10/14

Summary
Brief summary
This study will assess whether new cerals made with a new variant of barley deliver digestive health benefits to consumers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32265 0
Address 32265 0
Country 32265 0
Phone 32265 0
Fax 32265 0
Email 32265 0
Contact person for public queries
Name 15512 0
Dr Tony Bird
Address 15512 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC
SA 5000
Country 15512 0
Australia
Phone 15512 0
+61 8 8303 8902
Fax 15512 0
+61 8 8303 8899
Email 15512 0
[email protected]
Contact person for scientific queries
Name 6440 0
Dr Tony Bird
Address 6440 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC
SA 5000
Country 6440 0
Australia
Phone 6440 0
+61 8 8303 8902
Fax 6440 0
+61 8 8303 8899
Email 6440 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.