Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000888066
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
19/10/2010
Date last updated
19/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to examine the effects of rye bread on gastrointestinal bacteria in humans
Scientific title
A study to examine the effects of rye bread on gastrointestinal bacteria in humans
Secondary ID [1] 252888 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel health 258420 0
Condition category
Condition code
Oral and Gastrointestinal 258586 258586 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be a 4 week lead in period during which all the participants will consume their habitual diets. Faecal samples over a 48 hour period will be collected immediately prior to this period ,to determine habitual profiles, and then at the end of each subsequent fortnight of a 16 week study period.During the first 4 week intervention period half of the participants will be asked to consume a diet containing rye bread ,4 slices per day then crossover after 4 weeks washout period to the comparator treatment.
Intervention code [1] 257415 0
Lifestyle
Comparator / control treatment
There will be a 4 week lead in period during which all the participants will consume their habitual diets. Faecal samples over a 48 hour period will be collected immediately prior to this period ,to determine habitual profiles, and then at the end of each subsequent fortnight of a 16 week study period.During the first 4 week period half of the participants will be asked to consume a diet containing a control bread,4 slices of white bread per day then crossover after 4 weeks washout period to the intervention .
Control group
Active

Outcomes
Primary outcome [1] 259434 0
The primary outcome from this study will be a demonstration of whether consumption of a rye bread has a prebiotic effect in humans.
Timepoint [1] 259434 0
Faecal collection every 2 weeks for 16 weeks
Secondary outcome [1] 265981 0
To demonstratewhether rye bread consumption has beneficial effects on gut fermentation markers.
Timepoint [1] 265981 0
Faecal collection every 2 weeks for 16 weeks.
Secondary outcome [2] 266028 0
To demonstrate whether rye bread consumption has a beneficial effect on blood markers of inflammation.
Timepoint [2] 266028 0
Blood samples will be taken at the end of each 4 week phase and analysed for several inflammation markers.

Eligibility
Key inclusion criteria
Men or women aged 18 to 60 years
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence or history of gastrointestinal disease or other diseases like hepatic, renal or diabetes considered by CSIRO staff to potentially compromise results.
Use of antibiotics or probiotics within a month preceding the trial.Use of medicines that may influence the gut tissues or microflora within a month of the trial.
Known food allergy, hypersensitivity or intolerance to the study foods.Persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol. Participation in another research study within 30 days preceding the start of this study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257884 0
Commercial sector/Industry
Name [1] 257884 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 257884 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Conlon
Address
Commonwealth Scientific Industrial Research Organisation
Food and Nutritional Sciences
Gate 13
Kintore Ave
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 257062 0
None
Name [1] 257062 0
x
Address [1] 257062 0
x
Country [1] 257062 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 31786 0
Address 31786 0
Country 31786 0
Phone 31786 0
Fax 31786 0
Email 31786 0
Contact person for public queries
Name 15033 0
Mr Peter Royle
Address 15033 0
Office of the Centre Manager
Commonwealth Scientific Industrial Research Organisation Food and Nutritional Sciences
PO Box 10041
Adelaide 5000
South Australia
Country 15033 0
Australia
Phone 15033 0
+61 8 8303 8800
Fax 15033 0
Email 15033 0
[email protected]
Contact person for scientific queries
Name 5961 0
Dr Michael Conlon
Address 5961 0
Commonwealth Scientific Industrial Research Organisation Food and Nutritional Sciences
PO Box 10041
Adelaide 5000
South Australia
Country 5961 0
Australia
Phone 5961 0
+61 8 83038800
Fax 5961 0
Email 5961 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.