Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000998943
Ethics application status
Approved
Date submitted
7/08/2020
Date registered
6/10/2020
Date last updated
13/01/2023
Date data sharing statement initially provided
6/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
COPES 4 Bones: Combination of Physical Exercise and Synbiotic (pre- and probiotic) supplements for postmenopausal women
Scientific title
Modulation of bone/joint biomarkers, gut microbiota and inflammation status by synbiotics (pre and probiotics) and weight-bearing exercise in women with confirmed menopause
Secondary ID [1] 301971 0
Nil known
Universal Trial Number (UTN)
U1111-1256-6508
Trial acronym
COPES 4 Bones
Linked study record
This record is a follow-up/sub-study of ACTRN12617000802303

Health condition
Health condition(s) or problem(s) studied:
bone health 318532 0
Gut microbiota 318533 0
inflammation 318534 0
Menopause 318946 0
Condition category
Condition code
Inflammatory and Immune System 316538 316538 0 0
Other inflammatory or immune system disorders
Musculoskeletal 316539 316539 0 0
Osteoporosis
Musculoskeletal 316540 316540 0 0
Osteoarthritis
Oral and Gastrointestinal 316917 316917 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Reproductive Health and Childbirth 316918 316918 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 will receive pre- and pro-biotic supplements + low impact weight-bearing exercise
Arm 2 will be the control (maltodextrin placebo) + low impact weight-bearing exercise
Prebiotic supplement
10g of prebiotic fiber once daily for 12 weeks by oral capsule
Probiotic supplement
10 billion colony forming units (CFU) of probiotics such as Lactobacillus caseii once daily for 12 weeks by oral tablet
Adherence will be monitored by supplement tablet return
Low impact weight-bearing exercise (10,000 steps per day)
The exercise adherence will be monitored by a clip-on wearable fitness tracker by fitbit given to the recruited participants by the lead investigator and returned for analysis.
The women will be required to wear the fitness tracker daily and complete the exercise at home for 12 weeks.
The Borg Rating of Perceived Exertion (RPE) will be used to calculate intensity.
Intervention code [1] 318261 0
Treatment: Other
Intervention code [2] 318262 0
Lifestyle
Comparator / control treatment
The control group will not be required to take the placebo and exercise regime will be prescribed. The control group will also participate in the assessment of dietary intake, collection of blood, urine and faecal samples and self-report any physical activity at baseline and 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 324665 0
Change in bone mineral density by DEXA
Timepoint [1] 324665 0
Baseline and 12 weeks post-intervention commencement
Primary outcome [2] 325021 0
Bone biomarker cross-linked C-telopeptide of type 1 collagen (CTx-1) by serum assay
Timepoint [2] 325021 0
Baseline and 12 weeks post-intervention commencement
Secondary outcome [1] 385363 0
Change in inflammatory markers by BioLegend® LEGENDplex™ Multi-Analyte Flow Assay using plasma. The markers will include IL-1ß, IL-6, IL-8, IL-17, MCP-1, TNFa, IFN-a2, IFN-?, IL-10, IL-18, IL-33, IL-12 and IL-23.
Timepoint [1] 385363 0
Baseline and 12 weeks post-intervention commencement
Secondary outcome [2] 385364 0
Change in the gut microbial community by 16s ribosomal DNA sequencing using faecal sample.
Timepoint [2] 385364 0
Baseline and 12 weeks post-intervention commencement
Secondary outcome [3] 406204 0
Physical activity will be assessed by a fitness tracker (10,000 steps per day).
Timepoint [3] 406204 0
Baseline and 12 weeks

Eligibility
Key inclusion criteria
Confirmed menopause [by an initial blood test (baseline screening) that includes checking of levels of follicle-stimulating hormone (FSH greater than or equal to 30 mIU/mL) and oestrogen] of at least 5 years based on no menstruation. Body Mass Index (BMI) between 17 and 35 kg/m².
Minimum age
55 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of hormone replacement therapy (HRT).
2. Biphosphonates in last 6 months.
3. Currently on estrogen, tamoxifen, Aromatase Inhibitors or other antiresorptive or anabolic treatment of osteoporosis
4. Liver function test or creatinine above the normal range, or any other history suggesting liver or kidney disease to be confirmed by the baseline screening.
5. Incidence of diabetes mellitus by using the questionnaire and baseline screening.
6. Subjects with an estimated BMD T-score lower than -2.5 or fragility fracture in the previous 6 months.
7. Antibiotics intake in the previous 6 months
8. Smoking and intake of alcohol > 2 units per day.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by the numbered container.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by exercise history using Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Normality tests by Shapiro-Wilk tests. Analysis of variance (ANOVA) for pre- and post-test, multiple regression analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2022
Actual
17/04/2022
Date of last participant enrolment
Anticipated
1/06/2022
Actual
31/08/2022
Date of last data collection
Anticipated
1/10/2022
Actual
24/11/2022
Sample size
Target
120
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 22816 0
New Zealand
State/province [1] 22816 0
Manawatu-Wanganui

Funding & Sponsors
Funding source category [1] 306394 0
University
Name [1] 306394 0
Massey University
Country [1] 306394 0
New Zealand
Funding source category [2] 310759 0
Commercial sector/Industry
Name [2] 310759 0
Fonterra
Country [2] 310759 0
New Zealand
Primary sponsor type
University
Name
Massey University
Country
New Zealand
Secondary sponsor category [1] 306898 0
None
Name [1] 306898 0
None
Country [1] 306898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306593 0
Massey University Human Ethics Committee
Ethics committee address [1] 306593 0
Ethics committee country [1] 306593 0
New Zealand
Date submitted for ethics approval [1] 306593 0
03/09/2020
Approval date [1] 306593 0
23/03/2021
Ethics approval number [1] 306593 0
21/NTB/47

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 104402 0
Dr Bolaji Lilian Ilesanmi-Oyelere
Address 104402 0
Massey University School of Health Sciences College of Health Private bag 11 222 Manawatu campus Palmerston North 4442 New Zealand
Country 104402 0
New Zealand
Phone 104402 0
+642108522308
Fax 104402 0
Email 104402 0
b.ilesanmi-oyelere@massey.ac.nz
Contact person for public queries
Name 104403 0
Bolaji Lilian Ilesanmi-Oyelere
Address 104403 0
Massey University School of Health Sciences College of Health Private bag 11 222 Manawatu campus Palmerston North 4442 New Zealand
Country 104403 0
New Zealand
Phone 104403 0
+64 2108522308
Fax 104403 0
Email 104403 0
b.ilesanmi-oyelere@massey.ac.nz
Contact person for scientific queries
Name 104404 0
Bolaji Lilian Ilesanmi-Oyelere
Address 104404 0
Massey University School of Health Sciences College of Health Private bag 11 222 Manawatu campus Palmerston North 4442 New Zealand
Country 104404 0
New Zealand
Phone 104404 0
+64 2108522308
Fax 104404 0
Email 104404 0
b.ilesanmi-oyelere@massey.ac.nz

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sensitive data due to privacy and confidentiality



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8721Study protocol  b.ilesanmi-oyelere@massey.ac.nz
8723Statistical analysis plan  b.ilesanmi-oyelere@massey.ac.nz
8724Informed consent form  b.ilesanmi-oyelere@massey.ac.nz
8725Ethical approval  b.ilesanmi-oyelere@massey.ac.nz



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.