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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
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A three month randomised, prospective , single-blind controlled study to determine the effect of two dairy lipid preparations on bone and calcium metabolism in normal post-menopausal women.
Scientific title
Effect of Dairy Lipids on Bone Metabolism in Normal Post-Menopausal Women
Secondary ID [1] 288044 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Metabolism 3649 0
Condition category
Condition code
Metabolic and Endocrine 3817 3817 0 0
Normal metabolism and endocrine development and function

Study type
Description of intervention(s) / exposure
10 grams/day of one of two dairy lipid preparations containing stearic acid/12 weeks. Product A has 15 % stearic acid as a percentage of all fatty acids and
product B has 10 % stearic acid as a percentage of all fatty acids.
Intervention code [1] 3364 0
Treatment: Other
Comparator / control treatment
Normal diet/12 weeks
Control group
Dose comparison

Primary outcome [1] 4713 0
Serum markers of bone turnover - Serum total alkaline phosphatase, osteocalcin, P1NP and C-telopeptide.
Timepoint [1] 4713 0
baseline, 2,4 8 and 12 weeks
Secondary outcome [1] 7958 0
Urine markers of bone turnover - N-telopeptide and deoxypyridinoline
Timepoint [1] 7958 0
Baseline, 2, 4, 8 and 12 weeks
Secondary outcome [2] 7959 0
Bone mineral density in lumbar spine, proximal femur and total body on Lunar Prodigy Densitometer
Timepoint [2] 7959 0
Baseline and 3 months

Key inclusion criteria
Healthy women at least 5 years post -menopause
Minimum age
45 Years
Maximum age
80 Years
Can healthy volunteers participate?
Key exclusion criteria
Osteoporosis (Bone Mineral Density(BMD) T score <2.5 at hip or spine)
concurrent major systemic illness
renal impairment
chronic liver disease
active major gastrointestinal disease
metabolic bone diease
use of glucocorticoids in preceding 12 mths
use of bisphosphonates or Hormone Replacement Therapy (HRT) or other medications known to cause osteoporosis or interfere with bone metabolism.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible .participants will be allocated to one of three groups, normal diet, or one of two preparations of dairy lipids. Allocation is concealed by the use of numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using a variable block size schedule, based on computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

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 outside Australia
Country [1] 1195 0
New Zealand
State/province [1] 1195 0

Funding & Sponsors
Funding source category [1] 3828 0
Commercial sector/Industry
Name [1] 3828 0
Address [1] 3828 0
Private Bag 92032, Auckland,1010.
Country [1] 3828 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Private Bag 92032, Auckland, 1010.
New Zealand
Secondary sponsor category [1] 3437 0
Name [1] 3437 0
Address [1] 3437 0
Country [1] 3437 0

Ethics approval
Ethics application status
Ethics committee name [1] 5881 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5881 0
Private Bag 92 522
Wellesley St
Auckland Central 1010
Ethics committee country [1] 5881 0
New Zealand
Date submitted for ethics approval [1] 5881 0
Approval date [1] 5881 0
Ethics approval number [1] 5881 0

Brief summary
This research study aims to find out whether new preparations of dairy lipids, like butters, have any effectson bone metabolism that might help revent osteoporosis.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 28904 0
Prof Ian Reid
Address 28904 0
University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142
Country 28904 0
New Zealand
Phone 28904 0
+64 9 9236259
Fax 28904 0
Email 28904 0
Contact person for public queries
Name 12061 0
Dr Dr Anne Horne
Address 12061 0
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 12061 0
New Zealand
Phone 12061 0
64 9 9239787
Fax 12061 0
64 9 3072865
Email 12061 0
Contact person for scientific queries
Name 2989 0
Prof Professor Ian Reid
Address 2989 0
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 2989 0
New Zealand
Phone 2989 0
64 9 3737599 ext 86259
Fax 2989 0
Email 2989 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