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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001297314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/08/2026
Date registered
Help: Date registered
28/10/2026
Date last updated
Help: Date last updated
28/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Body composition and cardiometabolic health across the menopause transition in Australian women
Scientific title
Longitudinal trajectories of visceral adiposity and cardiometabolic risk across the menopause transition in Australian women: a prospective observational cohort study (MENO-BODY)
Additional trial identifiers [1] 318282 0
Nil
Universal Trial Number (UTN)
Trial acronym
MENO-BODY
Related trial records
ACTRN12615000116527 - substudy which include now a 10 year followup.
MATADOR 2: Minimising Adaptive Thermogenesis And Deactivating Obesity Rebound 2
Scientific title Effect of Intermittent Versus Continuous Energy Restriction on Body Weight, Resting Metabolic Rate and Neuroendocrine Function in Obese Women.

Health condition
Health condition(s) studied:
Menopause transition 342724 0
visceral adiposity 343398 0
cardiometabolic risk 343399 0
dyslipidaemia 343400 0
osteoperosis 343401 0
sarcopenia risk 343402 0
cognitive function 343403 0
Condition category
Condition code
Reproductive Health and Childbirth 338862 338862 0 0
Menstruation and menopause
Metabolic and Endocrine 339481 339481 0 0
Metabolic disorders
Cardiovascular 339482 339482 0 0
Other cardiovascular diseases
Musculoskeletal 339483 339483 0 0
Osteoporosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
MENO-BODY is a 5-year prospective longitudinal cohort study with annual assessments conducted at Bond University (Gold Coast, Queensland, Australia). Phase 1 includes 57 women previously enrolled in MATADOR-2, and Phase 2 will recruit an additional 400 community-dwelling women aged 40 to 65 years spanning premenopause, perimenopause, and early postmenopause according to the Stages of Reproductive Aging Workshop +10 (STRAW+10) criteria.

Participants will attend one annual in-person assessment visit and complete online questionnaires and cognitive assessments each year. Phase 1 and Phase 2 participants will undergo the same annual assessment but be analysed as separate cohorts.

Annual In-Person Assessments
The annual assessment visit will take approximately 3.5 to 4.5 hours and will include:

Anthropometry (height, weight, waist and hip circumference) (~15 min)
Body composition and bone mineral density assessment using dual-energy X-ray absorptiometry (DXA) (~20 min)
Fasting blood collection for cardiometabolic biomarkers including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, apolipoprotein B, glycated haemoglobin (HbA1c), high-sensitivity C-reactive protein (hs-CRP), and related biomarkers (~15 min)
Resting metabolic rate assessment via indirect calorimetry (~30 min)
Vascular function assessments including pulse wave velocity, flow-mediated dilatation, and carotid intima-media thickness (~15-20 min)
Physical function assessments including handgrip strength, sit-to-stand performance, balance, and gait speed (~20 min)
Walking economy assessment using indirect calorimetry during sitting, standing, walking, and stair-climbing tasks (~30-45 min) conducted on a separate day.

Online Cognitive Assessment
Participants will complete the National Institutes of Health (NIH) Toolbox Cognition Battery online annually (approximately 24 minutes total), consisting of:
Picture Sequence Memory Test (~7 min)
Flanker Inhibitory Control and Attention Test (~5 min)
Pattern Comparison Processing Speed Test (~5 min)
List Sorting Working Memory Test (~7 min)

Questionnaires
Participants will complete validated online questionnaires annually, requiring approximately 45 to 60 minutes in total, including:
Menopause-specific Quality of Life Questionnaire (MENQOL) (~10 min)
Greene Climacteric Scale (~5 min)
Short Form-36 Health Survey (SF-36) (~10 min)
Depression Anxiety Stress Scales (DASS-21) (~5 min)
Centre for Epidemiologic Studies Depression Scale (CES-D) (~5 min)
Multidimensional Health Locus of Control Questionnaire (~5 min)
Dutch Eating Behaviour Questionnaire (~10 min)
Food Frequency Questionnaire (~15-20 min)
Epworth Sleepiness Scale (~5 min)
SARC-F Sarcopenia Screening Questionnaire (~2 min)
International Physical Activity Questionnaire (IPAQ) (~5 min)

Participants will also complete annual health update questionnaires (~5 min) capturing changes in:
Medication use (type, dose, and frequency)
Menopausal hormone therapy use
Medical history and comorbidities

Total Participant Time Commitment
Annual in-person assessment visit: approximately 3.5-4.5 hours
Annual questionnaires: approximately 45-60 minutes
Annual online cognitive testing: approximately 24 minutes

Total annual participant burden: approximately 5-6 hours per year.
Intervention code [1] 334650 0
Not applicable
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346077 0
Visceral adipose tissue (VAT) area
Timepoint [1] 346077 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 -post enrolment
Primary outcome [2] 346079 0
LDL Cholesterol
Timepoint [2] 346079 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [1] 464508 0
Apolipoprotein B
Timepoint [1] 464508 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [2] 464509 0
HDL Cholesterol
Timepoint [2] 464509 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [3] 464510 0
hs-CRP
Timepoint [3] 464510 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [4] 464511 0
Lean Mass
Timepoint [4] 464511 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [5] 464512 0
Bone mineral density
Timepoint [5] 464512 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [6] 464513 0
Resting Metabolic Rate
Timepoint [6] 464513 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [7] 464514 0
Physical function indices
Timepoint [7] 464514 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [8] 464515 0
Menopause symptom severity
Timepoint [8] 464515 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [9] 466982 0
Vascular indices: brachial blood pressure, and where feasible carotid–femoral pulse wave velocity, central aortic pressures,
Timepoint [9] 466982 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [10] 466983 0
Cognitive function indices
Timepoint [10] 466983 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [11] 466984 0
Sleep quality
Timepoint [11] 466984 0
Baseline, Year 1, Year 2, Year 3, Year 4, Year 5 post-enrolment
Secondary outcome [12] 468136 0
walking economy (energy cost of movement/movement efficiency)
Timepoint [12] 468136 0
Baseline, Year 1, 2, 3, 4 and 5 post-enrolment

Eligibility
Key inclusion criteria
Phase-specific eligibility:
- Phase 1: Previous participation in MATADOR-2.
- Phase 2: Women aged 40–65 years meeting menopausal status definitions below.

Demographics: Women aged 40–65 years at enrolment; capacity to provide informed consent; sufficient English proficiency for questionnaire completion.

Health status: BMI greater than or equal to 18.5 kg/m²; ambulatory; willing to maintain current lifestyle throughout the study period and report any significant changes; available for 2–5 years of follow-up.

Reproductive history: Natural menopause where applicable; not pregnant or breastfeeding in the preceding 12 months; not planning pregnancy.

Medication stability: Stable medication regimen for at least 3 months prior to enrolment; willing to report any changes throughout follow-up.
Minimum age
40 Years
Maximum age
65 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Unable to attend Bond University for assessments;
declines annual follow-up participation;
current or planned surgical/chemical menopause during study period;
Bilateral oophorectomy or hysterectomy;
Pregnancy or planned pregnancy during the follow-up period
Inability to attend the study site for annual assessments

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The planned sample size is approximately 460 participants, comprising 60 legacy MATADOR-2 participants and 400 newly recruited participants from the community. This target was determined pragmatically based on the available MATADOR-2 registry, anticipated recruitment yield, and the feasibility of maintaining annual longitudinal assessments over a five-year follow-up period.
Based on existing longitudinal cohort studies in midlife women, total attrition is expected to be approximately 20-25% over the 5-year follow-up period. Given the absence of directly comparable longitudinal data incorporating menopausal stage, hormonal trajectories, and body composition within a unified framework, formal power calculations were not used to determine the initial recruitment target. Instead, this sample size is considered sufficient to support linear mixed-effects modelling of longitudinal trajectories and to provide adequate precision for estimation of within- and between-person effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2028
Actual
Date of last data collection
Anticipated
30/11/2033
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 46474 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 322198 0
University
Name [1] 322198 0
Bond University Honours Funding
Country [1] 322198 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Country
Australia
Secondary sponsor category [1] 325107 0
None
Name [1] 325107 0
Address [1] 325107 0
Country [1] 325107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320722 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 320722 0
Ethics committee country [1] 320722 0
Australia
Date submitted for ethics approval [1] 320722 0
07/05/2025
Approval date [1] 320722 0
07/05/2025
Ethics approval number [1] 320722 0
HO01019_v1

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

Contacts
Principal investigator
Name 151414 0
Dr Hayley O'Neill
Address 151414 0
Bond University, 14 University Dr, Robina, 4226, QLD
Country 151414 0
Australia
Phone 151414 0
+61 7 5595 1273
Fax 151414 0
Email 151414 0
[email protected]
Contact person for public queries
Name 151415 0
Hayley O'Neill
Address 151415 0
Bond University, 14 University Dr, Robina, 4226, QLD
Country 151415 0
Australia
Phone 151415 0
+61 7 5595 1273
Fax 151415 0
Email 151415 0
[email protected]
Contact person for scientific queries
Name 151416 0
Hayley O'Neill
Address 151416 0
Bond University, 14 University Dr, Robina, 4226, QLD
Country 151416 0
Australia
Phone 151416 0
+61 7 5595 1273
Fax 151416 0
Email 151416 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data will be analysed in aggregate



What supporting documents are/will be available?

No Supporting Document Provided


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.