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
ACTRN12611001105932
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
24/10/2011
Date last updated
17/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Determination of the Impact of Different Cereals on Mineral Status
Scientific title
Determination of the Impact of Cereal Consumption on Mineral Status in Postmenopausal Women
Secondary ID [1] 273237 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
normal mineral bioavailability 278997 0
Condition category
Condition code
Diet and Nutrition 279179 279179 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will be testing 4 cereals that differ in their nutrient composition. The 4 cereal types will deliver 1. high, 2. moderate-high, 3. moderate or 4. low (negative control) levels of dietary fibre. For the study duration participants will follow their habitual dietary pattern with some restrictions to ensure it is low in fibre. This is a parallel study design, with participants randomised to one of four groups. Participants will be asked to consume 100g of the test food daily for an 8 week testing period. At baseline participants will undergo a DXA total body, forearm and lumbar spine scan. Each fortnight participants will attend the clinic for a fasted blood sample and to complete 2 short questionnaires (product consumption checklist and 3 day food diary) and prior to the visit collect a 48 hour urine. At week 8 participants will undergo a dual stable isotope test.
Intervention code [1] 269571 0
Prevention
Intervention code [2] 269578 0
Lifestyle
Comparator / control treatment
refined cereal - low fibre negative control
Control group
Active

Outcomes
Primary outcome [1] 279823 0
calcium absorption - dual stable isotope laboratory analysis
Timepoint [1] 279823 0
week 8
Secondary outcome [1] 294515 0
mineral balance - urine laboratory analysis
Timepoint [1] 294515 0
baseline, week 2, 4, 6, 8
Secondary outcome [2] 294516 0
DXA scan for bone mineral density
Timepoint [2] 294516 0
baseline
Secondary outcome [3] 294517 0
calcium and bone biomarkers - laboratory blood analysis
Timepoint [3] 294517 0
baseline, week 2, 4, 6, 8

Eligibility
Key inclusion criteria
female, aged <75 years, postmenopausal >6years and not undergoing hormone replacement therapy.
Not on vitamin or mineral supplements or unwilling to abstain for the duration of the study.
Not received any medication that in the opinion of the investigator could interfere with the study and no medications likely to modulate gut and/or metabolic function.
Minimum age
No limit
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Bone mineral density in the osteoporotic density range.
Intolerance to lactose.
Use of any form of drug therapy or medication or supplements that may interfere with bowel or bone function (such as antibiotics, laxatives, osteoporotic treatments 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.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified block randomisation
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2012
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
31/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270070 0
Government body
Name [1] 270070 0
CSIRO Food Futures National Research Flagship
Country [1] 270070 0
Australia
Primary sponsor type
Government body
Name
CSIRO Food Futures National Research Flagship
Address
PO Box 10041
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 269036 0
None
Name [1] 269036 0
Address [1] 269036 0
Country [1] 269036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272025 0
CFNS Human Research Ethics Committee
Ethics committee address [1] 272025 0
PO Box 10041
Adelaide SA 5000
Ethics committee country [1] 272025 0
Australia
Date submitted for ethics approval [1] 272025 0
21/10/2011
Approval date [1] 272025 0
29/02/2012
Ethics approval number [1] 272025 0
CFNS HREC 11/15

Summary
Brief summary
This study will assess whether cereals can improve mineral bioavailability in postmenopausal women.
Trial website
Trial related presentations / publications
N/A to date
Public notes

Contacts
Principal investigator
Name 33284 0
Dr Dr Tony Bird
Address 33284 0
CSIRO Food and Nutritional Sciences PO Box 10041 Adelaide SA 5000
Country 33284 0
Australia
Phone 33284 0
+61 8 8303 8902
Fax 33284 0
Email 33284 0
[email protected]
Contact person for public queries
Name 16531 0
Dr Dr Tony Bird
Address 16531 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide SA 5000
Country 16531 0
Australia
Phone 16531 0
+61 8 8303 8902
Fax 16531 0
+61 8 8303 8899
Email 16531 0
[email protected]
Contact person for scientific queries
Name 7459 0
Dr Dr Tony Bird
Address 7459 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide SA 5000
Country 7459 0
Australia
Phone 7459 0
+61 8 8303 8902
Fax 7459 0
+61 8 8303 8899
Email 7459 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.