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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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
Intervention code [2] 269578 0
Comparator / control treatment
refined cereal - low fibre negative control
Control group

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
Secondary outcome [3] 294517 0
calcium and bone biomarkers - laboratory blood analysis
Timepoint [3] 294517 0
baseline, week 2, 4, 6, 8

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
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Address [1] 270070 0
PO Box 10041
Adelaide SA 5000
Country [1] 270070 0
Primary sponsor type
Government body
CSIRO Food Futures National Research Flagship
PO Box 10041
Adelaide SA 5000
Secondary sponsor category [1] 269036 0
Name [1] 269036 0
Address [1] 269036 0
Country [1] 269036 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 272025 0
Approval date [1] 272025 0
Ethics approval number [1] 272025 0

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

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
Phone 33284 0
+61 8 8303 8902
Fax 33284 0
Email 33284 0
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
Phone 16531 0
+61 8 8303 8902
Fax 16531 0
+61 8 8303 8899
Email 16531 0
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
Phone 7459 0
+61 8 8303 8902
Fax 7459 0
+61 8 8303 8899
Email 7459 0

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