Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000431426
Ethics application status
Approved
Date submitted
2/04/2025
Date registered
9/05/2025
Date last updated
9/05/2025
Date data sharing statement initially provided
9/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of BoneBoost Gelato on markers of musculoskeletal health
Scientific title
The effect of BoneBoost Gelato on markers of musculoskeletal health in healthy, postmenopausal women over the age of 60.
Secondary ID [1] 314075 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone turnover (resorption and formation) 336887 0
Osteoporosis 336889 0
Sarcopenia 336893 0
Condition category
Condition code
Musculoskeletal 333360 333360 0 0
Osteoporosis
Musculoskeletal 333361 333361 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily consumption of one serve (125g) of BoneBoost Gelato, over the four week intervention period (T1-T2). BoneBoost Gelato is a nutrient-dense, whole food based gelato (ice cream) that has been formulated to contain ~50% of the recommended daily intake (RDI) for both calcium and vitamin D, 20% of the RDI for protein, and the equivalent of ~2 standard serves of vegetables and 1 serve of fruit. Intervention adherence will be assessed via a daily food consumption record throughout the four week intervention period (T1-T2).
Intervention code [1] 330677 0
Lifestyle
Intervention code [2] 330681 0
Treatment: Other
Comparator / control treatment
This pilot study will adopt a single arm pragmatic clinical trial design. It will comprise of an initial 4-week observational period to provide a reference point (control, T0-T1). The subsequent 4-week intervention period will follow (intervention, T1-T2).
Control group
Active

Outcomes
Primary outcome [1] 340938 0
Marker of bone resorption.
Timepoint [1] 340938 0
Serum/plasma bone resorption markers (CTX) will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Primary outcome [2] 341183 0
Bone formation marker.
Timepoint [2] 341183 0
To assess bone formation, serum OC will be measured at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Primary outcome [3] 341291 0
Marker of bone resorption.
Timepoint [3] 341291 0
Serum/plasma bone resorption markers (B-ALP) will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [1] 445530 0
Vitamin D status.
Timepoint [1] 445530 0
Vitamin D status will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [2] 445531 0
Anthropometry.
Timepoint [2] 445531 0
Anthropometry will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [3] 445532 0
Blood pressure.
Timepoint [3] 445532 0
Blood pressure will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [4] 445533 0
Muscle strength.
Timepoint [4] 445533 0
Muscle strength will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [5] 446694 0
Blood glucose levels.
Timepoint [5] 446694 0
Blood glucose will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [6] 446695 0
Glycated haemoglobin (HbA1c) measurement.
Timepoint [6] 446695 0
Glycated haemoglobin (HbA1c) will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [7] 446696 0
Vitamin K status.
Timepoint [7] 446696 0
Vitamin K status biomarkers will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [8] 446697 0
Body composition.
Timepoint [8] 446697 0
Body composition will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [9] 446698 0
Physical function.
Timepoint [9] 446698 0
Physical function will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [10] 447024 0
Total blood cholesterol
Timepoint [10] 447024 0
Total blood cholesterol will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [11] 447025 0
HDL-cholesterol
Timepoint [11] 447025 0
HDL-cholesterol levels will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [12] 447027 0
Triglycerides
Timepoint [12] 447027 0
Blood triglycerides will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),
Secondary outcome [13] 447028 0
LDL-cholesterol
Timepoint [13] 447028 0
LDL-cholesterol will be assessed at baseline (T0), after 4 weeks (weeks 1-4) of observation (T1) and following the subsequent four weeks (weeks 4-8) of intervention (T2),

Eligibility
Key inclusion criteria
Healthy, ambulant, community-dwelling post-menopausal older women residing in Western Australia.
Minimum age
60 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
(i) Women taking any bone active medications, anticoagulants (e.g. Warfarin) or calcium/vitamin D or multivitamin supplements;
(ii) Those with a history of vascular disease or chest pain suggestive of angina pectoris;
(iii) Women with significant co-morbidities, such as end stage renal disease, systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg;
(iv) Individuals currently presenting with a well-balanced and healthy diet which meets the Australian Guide to Healthy Eating (AGHE), especially in relation to vegetable, fruit, protein and/or calcium intake;
(v) Those unable or unwilling to follow the study protocol (including those with relevant food allergies), or those without access or inability to use a computer/smart device.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear-mixed models will examine the effect of the intervention (BoneBoost Gelato) on Bone Turnover Markers between follow-ups (T0-T1 vs. T1-T2). Post-treatment differences (and absolute change) for Bone Turnover Markers will include additional adjustments for pre-intervention levels. A similar approach will be adopted for all secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318583 0
Charities/Societies/Foundations
Name [1] 318583 0
Australian and New Zealand Bone and Mineral Society (ANZBMS)
Country [1] 318583 0
Australia
Funding source category [2] 318616 0
Charities/Societies/Foundations
Name [2] 318616 0
Bone Health Foundation (BHF)
Country [2] 318616 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 321018 0
None
Name [1] 321018 0
Address [1] 321018 0
Country [1] 321018 0
Other collaborator category [1] 283454 0
University
Name [1] 283454 0
The University of Western Australia
Address [1] 283454 0
Country [1] 283454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317180 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 317180 0
Ethics committee country [1] 317180 0
Australia
Date submitted for ethics approval [1] 317180 0
20/01/2025
Approval date [1] 317180 0
23/04/2025
Ethics approval number [1] 317180 0
2024-06029-SIM

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

Contacts
Principal investigator
Name 140266 0
Dr Marc Sim
Address 140266 0
School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 140266 0
Australia
Phone 140266 0
+61 8 6304 4605
Fax 140266 0
Email 140266 0
[email protected]
Contact person for public queries
Name 140267 0
Marc Sim
Address 140267 0
School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 140267 0
Australia
Phone 140267 0
+61 8 6304 4605
Fax 140267 0
Email 140267 0
[email protected]
Contact person for scientific queries
Name 140268 0
Marc Sim
Address 140268 0
School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 140268 0
Australia
Phone 140268 0
+61 8 6304 4605
Fax 140268 0
Email 140268 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24595Informed consent form    A Participant Information form_revised Clean.docx



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.