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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
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Scientific title
The effect of BoneBoost Gelato on markers of musculoskeletal health in healthy, postmenopausal women over the age of 60.
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Secondary ID [1]
314075
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bone turnover (resorption and formation)
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Osteoporosis
336889
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Sarcopenia
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Condition category
Condition code
Musculoskeletal
333360
333360
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0
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Osteoporosis
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Musculoskeletal
333361
333361
0
0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
330677
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Lifestyle
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Intervention code [2]
330681
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Treatment: Other
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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Marker of bone resorption.
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Assessment method [1]
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Serum/plasma C-terminal telopeptide of type 1 collagen (CTX)
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Timepoint [1]
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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),
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Primary outcome [2]
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Bone formation marker.
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Assessment method [2]
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Serum Osteocalcin (OC).
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Timepoint [2]
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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),
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Primary outcome [3]
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Marker of bone resorption.
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Assessment method [3]
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Serum/plasma alkaline phosphatase (bone specific) (B-ALP)..
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Timepoint [3]
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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),
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Secondary outcome [1]
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Vitamin D status.
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Assessment method [1]
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Standard biochemical measurement of serum 25-hydroxy vitamin D (25OHD) will be used to measure vitamin D status.
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Timepoint [1]
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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),
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Secondary outcome [2]
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Anthropometry.
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Assessment method [2]
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Body mass and height will be measured using digital scales and a wall mounted stadiometer, respectively, Weight (kg) divided by height (m) squared will be used to calculate BMI (kg/m2).
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Timepoint [2]
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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),
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Secondary outcome [3]
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Blood pressure.
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Assessment method [3]
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Blood pressure will be measured using a Dinamap 1846SX/P oscillometric recorder (Critikon Inc., Tampa, FL, USA). Five blood pressure measurements will be performed at 1-minute intervals and the last 4 measurements averaged.
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Timepoint [3]
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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),
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Secondary outcome [4]
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Muscle strength.
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Assessment method [4]
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Handgrip strength of the dominant hand will be recorded as the highest of three attempts using a handheld dynamometer (Jamar Hydraulic Hand Grip Dynamometer).
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Timepoint [4]
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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),
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Secondary outcome [5]
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Blood glucose levels.
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Assessment method [5]
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Standard biochemical measurement of blood glucose concentrations.
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Timepoint [5]
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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),
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Secondary outcome [6]
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Glycated haemoglobin (HbA1c) measurement.
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Assessment method [6]
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Standard biochemical measurement HbA1c concentrations.
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Timepoint [6]
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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),
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Secondary outcome [7]
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Vitamin K status.
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Assessment method [7]
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The ratio of undercarboxylated to total osteocalcin (ucOC:tOC), determined based on serum total and undercarboxylated OC measurements, will be used to assess vitamin K status.
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Timepoint [7]
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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),
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Secondary outcome [8]
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Body composition.
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Assessment method [8]
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Bioelectrical impedance (BIA) scales will be used to provide body composition estimates, including whole body lean and fat mass.
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Timepoint [8]
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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),
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Secondary outcome [9]
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Physical function.
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Assessment method [9]
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Timed Up-and-Go (TUG) will be used to assess mobility, the fastest of two attempts, following one practice trial, will be reported.
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Timepoint [9]
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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),
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Secondary outcome [10]
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Total blood cholesterol
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Assessment method [10]
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Standard biochemical measurement of blood lipid panels, including total cholesterol.
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Timepoint [10]
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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),
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Secondary outcome [11]
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HDL-cholesterol
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Assessment method [11]
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Standard biochemical measurement of blood lipid panels, including HDL-cholesterol.
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Timepoint [11]
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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),
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Secondary outcome [12]
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Triglycerides
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Assessment method [12]
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Standard biochemical measurement of blood lipid panels, including triglycerides.
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Timepoint [12]
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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),
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Secondary outcome [13]
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LDL-cholesterol
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Assessment method [13]
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LDL-cholesterol levels will be determined via the Friedewald formula, using the standard biochemical measurements of; total cholesterol, HDL-cholesterol, and triglycerides.
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Timepoint [13]
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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),
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Eligibility
Key inclusion criteria
Healthy, ambulant, community-dwelling post-menopausal older women residing in Western Australia.
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Minimum age
60
Years
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Maximum age
80
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/05/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2026
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Actual
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Date of last data collection
Anticipated
30/12/2027
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australian and New Zealand Bone and Mineral Society (ANZBMS)
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Bone Health Foundation (BHF)
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Address [2]
318616
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Country [2]
318616
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Australia
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Primary sponsor type
University
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Name
Edith Cowan University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
321018
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Other collaborator category [1]
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University
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Name [1]
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The University of Western Australia
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Address [1]
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Country [1]
283454
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317180
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Edith Cowan University Human Research Ethics Committee
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Ethics committee address [1]
317180
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http://www.ecu.edu.au/GPPS/ethics
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Ethics committee country [1]
317180
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Australia
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Date submitted for ethics approval [1]
317180
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20/01/2025
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Approval date [1]
317180
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23/04/2025
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Ethics approval number [1]
317180
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2024-06029-SIM
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Summary
Brief summary
Older women are at a much higher risk for osteoporosis (weak bones) and fracture, compared to men. When considering diet, often only calcium, vitamin D and protein are promoted for muscle and bone health. Yet an overall balanced diet is critical to optimise musculoskeletal health. In addition to protein, calcium and vitamin D, key nutrients from vegetables and fruits also play an important role. However, improving dietary habits, such as increasing fruit and vegetable intake, is challenging. To overcome this limitation, BoneBoost Gelato, a nutrient-dense, whole food ice cream containing a variety of key nutrients shown support musculoskeletal health, has been developed. This pilot study seeks to examine the effects of 4-weeks of daily BoneBoost Gelato consumption on markers of bone health in older women.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Marc Sim
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Address
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School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
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Country
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Australia
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Phone
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+61 8 6304 4605
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Fax
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Email
140266
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[email protected]
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Contact person for public queries
Name
140267
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Marc Sim
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Address
140267
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School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
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Country
140267
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Australia
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Phone
140267
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+61 8 6304 4605
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Fax
140267
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Email
140267
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[email protected]
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Contact person for scientific queries
Name
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Marc Sim
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Address
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School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
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Country
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Australia
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Phone
140268
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+61 8 6304 4605
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Fax
140268
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Email
140268
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24595
Informed 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.
Download to PDF