Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001447549p
Ethics application status
Submitted, not yet approved
Date submitted
7/11/2024
Date registered
12/12/2024
Date last updated
12/12/2024
Date data sharing statement initially provided
12/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of milk ingredients on mind and movement of older women
Scientific title
The effects of Dairy Ingredients on Stress, Mental Wellness and Physical Performance in Postmenopausal Women
Secondary ID [1] 312771 0
Fonterra project 1015760
Universal Trial Number (UTN)
Trial acronym
MIGHTY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 334811 0
Physical function 334812 0
Condition category
Condition code
Mental Health 331372 331372 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 331373 331373 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a parallel group, double blind randomised controlled trial design. Over 12 weeks, approximately 4g of a milk ingredient will be compared to an energy matched maltodextrin control. Both will be provided as a powder in a single serve sachet to be taken once per day mixed in a usual beverage as a supplement to their usual diet. Compliance/adherence will be monitored by return of sachets. The nutritional intervention will run alongside a home-based light exercise and walking intervention.
Subjects will visit the Massey University Human Performance Laboratory at baseline and at end of intervention for musculoskeletal function tests and general health status. Stress, coping and memory tests will be assessed at home by relevant online questionnaires at baseline, middle and at end of intervention.
Intervention code [1] 329717 0
Treatment: Other
Comparator / control treatment
Energy matched placebo consisting of maltodextrin as a powder in a single serve sachet to be taken once per day mixed in a usual beverage in addition to their usual diet.
Control group
Placebo

Outcomes
Primary outcome [1] 339584 0
Stress
Timepoint [1] 339584 0
Baseline, 6- and 12-weeks post-commencement of intervention
Primary outcome [2] 339585 0
Memory
Timepoint [2] 339585 0
Baseline, 6- and 12-weeks post-commencement of intervention
Secondary outcome [1] 440512 0
Strength
Timepoint [1] 440512 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [2] 440513 0
Neuromuscular performance
Timepoint [2] 440513 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [3] 440514 0
Whole body composition
Timepoint [3] 440514 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [4] 440515 0
Lipid profile
Timepoint [4] 440515 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [5] 442200 0
Physical function
Timepoint [5] 442200 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [6] 442201 0
Physical function
Timepoint [6] 442201 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [7] 442202 0
Balance
Timepoint [7] 442202 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [8] 442203 0
Long term glucose control
Timepoint [8] 442203 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [9] 442205 0
Marker of Inflammation
Timepoint [9] 442205 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [10] 442518 0
Lipid profile
Timepoint [10] 442518 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [11] 442519 0
Lipid profile
Timepoint [11] 442519 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [12] 442522 0
Lipid profile
Timepoint [12] 442522 0
Baseline and 12 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
Healthy women aged 65 - 80 years with body mass index (BMI) not less than 20 and not more than 35 kg/m2, and non-athletes with moderate physical activity and stressed as according to a Perceived Stress Scale score of higher than 14.
Minimum age
65 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers, heavy alcohol consumers, use hormone replacement therapy, suffer from chronic diseases (such as Diabetes and chronic kidney disease), mal-absorptive diseases (such as Crohn disease, Ulcerative colitis, and Coeliac), and suffer from Lactose intolerance or allergy to dairy will be excluded. Also, volunteers who are suddenly diagnosed with systemic diseases or mental disorders will be excluded through the follow-up.

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 involves contacting the holder of the allocation schedule who is "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. Computerised sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2025
Actual
Date of last participant enrolment
Anticipated
6/01/2026
Actual
Date of last data collection
Anticipated
7/04/2026
Actual
Sample size
Target
94
Accrual to date
Final
Recruitment outside Australia
Country [1] 26624 0
New Zealand
State/province [1] 26624 0

Funding & Sponsors
Funding source category [1] 317204 0
Commercial sector/Industry
Name [1] 317204 0
Fonterra Co-operative Group limited
Country [1] 317204 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Co-operative Group limited
Address
Country
New Zealand
Secondary sponsor category [1] 319894 0
University
Name [1] 319894 0
Massey University
Address [1] 319894 0
Country [1] 319894 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315942 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315942 0
Ethics committee country [1] 315942 0
New Zealand
Date submitted for ethics approval [1] 315942 0
30/10/2024
Approval date [1] 315942 0
Ethics approval number [1] 315942 0

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

Contacts
Principal investigator
Name 136294 0
Prof Marlena Kruger
Address 136294 0
Massey University, Private Bag 11222, Palmerston North 4442, New Zealand
Country 136294 0
New Zealand
Phone 136294 0
+64 6 951 7571
Fax 136294 0
Email 136294 0
M.C.Kruger@massey.ac.nz
Contact person for public queries
Name 136295 0
Marlena Kruger
Address 136295 0
Massey University, Private Bag 11222, Palmerston North 4442, New Zealand
Country 136295 0
New Zealand
Phone 136295 0
+64 6 951 7571
Fax 136295 0
Email 136295 0
M.C.Kruger@massey.ac.nz
Contact person for scientific queries
Name 136296 0
Marlena Kruger
Address 136296 0
Massey University, Private Bag 11222, Palmerston North 4442, New Zealand
Country 136296 0
New Zealand
Phone 136296 0
+64 6 951 7571
Fax 136296 0
Email 136296 0
M.C.Kruger@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification; individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor and or Principal investigator.
Available for what types of analyses?
To achieve the aims in the approved proposal, for IPD meta-analyses, etc.
How or where can data be obtained?
Access subject to approvals by Principal Investigator and or Primary Sponsor
M.C.Kruger@massey.ac.nz


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.