Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001720808
Ethics application status
Approved
Date submitted
10/11/2021
Date registered
16/12/2021
Date last updated
16/12/2021
Date data sharing statement initially provided
16/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Employing Milk Proteins to Observe Wellbeing and Emotional Resilience in healthy adults
Scientific title
Employing Milk Proteins to Observe Wellbeing and Emotional Resilience in healthy adults: a double blind, placebo controlled trial
Secondary ID [1] 305732 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMPOWER
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Stress 324224 0
Condition category
Condition code
Mental Health 321707 321707 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
AIMS
This study aims to investigate the relationship between Milk Fat Globular Membrane (MFGM) supplementation, psychological wellbeing, sleep, and cognitive function in healthy adults. The study will be hypothesis generating and inform future larger trials.
METHODS
This study has been designed to run under any public health restrictions during the global pandemic. It will be a nationwide study, where all questionnaires, assessments, and interviews can be done remotely and via zoom. This allows a broader population for recruitment and minimises the impact of changing alert levels on data collection.

This study has three data collection time points: baseline, mid-intervention, and post-intervention.
Baseline Assessment: Timepoint one
Once consent and demographic data collection is complete, participants will be sent a wearable Fitbit Charge 4 wrist watch, with instructions to wear it for two weeks to provide pre-study reference data.
After the two-week Fitbit reference data collection period, participants will be sent a link to complete baseline questionnaires (DASS, WHO-5, PSQ), a separate link to complete cognitive assessment measures (Cambridge Neuropsychological Test Automated Battery CANTAB), and a posted home saliva cortisol test kit with instructions and postage paid return pack. Participants will be sent the supplement sachets at this time point.
Intervention:
Participants will be randomly assigned to receive 600mg of MFGM supplement, 1200mg of MFGM supplement, or placebo. Participants will be asked to take the powder daily, with food or drink for 12 weeks. Fonterra co-operative Group Limited will provide the MFGM supplement and placebo and all products will be manufactured to pharmaceutical grade. Lipid 100 is the name for the MFGM Fonterra product which is Buttermilk. Buttermilk contains about 20% MFGM and the rest is lactose and protein and other naturally occurring fats. Both the MFGM powder and placebo powder are gluten free and can be mixed with food or drink.
Adherence Monitoring: Email or text messages (according to participant preference) will be sent fortnightly to remind participants to take the supplement daily.
Mid-point assessment:
At the mid-point of the intervention (6 weeks after starting the supplement) participants will be sent out a saliva collection kit to provide a sample and send it back. Participants will also be sent a link to complete the same questionnaires as they did at baseline (DASS, WHO-5, PSQ).
Post-intervention Assessment:
One week before the participant is due to complete the intervention, saliva collection kits will be sent out. Participants will be asked to collect the saliva sample and send it back using the pre-paid postage bag provided.
At the end of the intervention period, participants will be sent an electronic link to complete the cognitive assessment (CANTAB) and the same questionnaires as they did at baseline (DASS, WHO-5, PSQ). Participants will select an appointment time for a post-intervention interview This can be done in person or via zoom according to participant preference. Participants will be guided through a semi-structured interview about general well-being, stress, and sleep quality that consists of 14 questions and should last up to 30 minutes in duration.
Intervention code [1] 322128 0
Treatment: Other
Comparator / control treatment
Placebo controlled. The placebo is maltodextrin powder.
Control group
Placebo

Outcomes
Primary outcome [1] 329467 0
Depression, Anxiety, and Stress Scale: A 21-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress. This questionnaire will take the participants approximately 3-5 minutes to complete.
Timepoint [1] 329467 0
End point, 12 weeks after the intervention start date.
Secondary outcome [1] 402708 0
World Health Organisation Well-being index: The WHO-5 questionnaire is a positively worded psychological measure of well-being. It is a 5-item questionnaire that asks people to rate their energy, rest, and well-being. This questionnaire will take the participants roughly 1 minute to complete.
Timepoint [1] 402708 0
This time point will be assessed at 6 weeks after the commencement of the intervention and 12 weeks after the commencement of the intervention.
Secondary outcome [2] 402709 0
Pittsburgh Sleep Quality index: The PSQ is a 9-item questionnaire that is used to measure the quality and patterns of sleep in adults. It differentiates “poor” from “good” sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. This questionnaire will take the participants approximately 2 minutes to complete.
Timepoint [2] 402709 0
This time point will be assessed at 6 weeks after the commencement of the intervention and 12 weeks after the commencement of the intervention.
Secondary outcome [3] 402710 0
Salivary cortisol concentrations
Timepoint [3] 402710 0
This time point will be assessed at 6 weeks after the commencement of the intervention and 12 weeks after the commencement of the intervention.
Secondary outcome [4] 402711 0
Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive assessment
Participants will complete measures of different cognitive abilities using their own home computer and a web-based cognitive assessment battery
Timepoint [4] 402711 0
This time point will be assessed at 12 weeks after the commencement of the intervention.
Secondary outcome [5] 402712 0
Heart rate variability as measured through a Fitbit Charge 4 wristwatch.
Timepoint [5] 402712 0
This time point will be assessed at 12 weeks after the commencement of the intervention.
Secondary outcome [6] 402713 0
The ratio of time spent in vigorous, moderate and mild physical activity as measured through a Fitbit Charge 4 wristwatch will be measured as a single composite outcome.
Timepoint [6] 402713 0
This time point will be assessed at 12 weeks after the commencement of the intervention.
Secondary outcome [7] 402714 0
Sleep efficiency score as measured through a Fitbit Charge 4 wristwatch.
Timepoint [7] 402714 0
This time point will be assessed at 12 weeks after the commencement of the intervention.

Eligibility
Key inclusion criteria
- Adults aged between 25-60 years old
- Currently living in New Zealand
- Have access to a smart phone, internet and computer.
- Report moderate levels of perceived stress.
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Are currently taking medication for depression or anxiety
- Have had antibiotics within the previous month
- Are intolerant or allergic to dairy products
- Regularly take probiotics or MFGM.

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)
Participants will receive their supplements in numbered foil packets. Randomisation will be carried out off-site by Fonterra when the supplements are packaged. Participants will be assigned a study ID in the order that they register for the study. This number will correspond to the number on their supplements. The researchers and participants will only be able to see the ID numbers on the packaging.
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).
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
Efficacy
Statistical methods / analysis
This is an exploratory study and sample size may limit the ability to detect statistically significant group differences. T-tests will analyse differences between intervention groups in cognitive test performance, psychological wellbeing, sleep, salivary cortisol, and objective physical activity and sleep measures from the Fitbit.
The qualitative interview data will be analysed using thematic analysis coded by two independent researchers, which is considered best practice in the handling of qualitative data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/01/2022
Actual
Date of last participant enrolment
Anticipated
1/04/2022
Actual
Date of last data collection
Anticipated
31/07/2022
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 24295 0
New Zealand
State/province [1] 24295 0

Funding & Sponsors
Funding source category [1] 310090 0
Commercial sector/Industry
Name [1] 310090 0
Fonterra Co-operative Ltd.
Country [1] 310090 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
22-30 Park Road
Grafton, Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 311172 0
None
Name [1] 311172 0
None
Address [1] 311172 0
None
Country [1] 311172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309780 0
Central Health and Disability Ethics Committees
Ethics committee address [1] 309780 0
Ethics committee country [1] 309780 0
New Zealand
Date submitted for ethics approval [1] 309780 0
26/10/2021
Approval date [1] 309780 0
30/11/2021
Ethics approval number [1] 309780 0

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

Contacts
Principal investigator
Name 115362 0
Dr Rebecca Slykerman
Address 115362 0
Department of Psychological Medicine,
The University of Auckland
22-30 Park Road
Grafton
Auckland, 1023
Country 115362 0
New Zealand
Phone 115362 0
+6499231132
Fax 115362 0
Email 115362 0
[email protected]
Contact person for public queries
Name 115363 0
Rebecca Slykerman
Address 115363 0
Department of Psychological Medicine,
The University of Auckland
22-30 Park Road
Grafton
Auckland, 1023
Country 115363 0
New Zealand
Phone 115363 0
+6499231132
Fax 115363 0
Email 115363 0
[email protected]
Contact person for scientific queries
Name 115364 0
Rebecca Slykerman
Address 115364 0
Department of Psychological Medicine,
The University of Auckland
22-30 Park Road
Grafton
Auckland, 1023
Country 115364 0
New Zealand
Phone 115364 0
+6499231132
Fax 115364 0
Email 115364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The individual level data will not be made available due to ethics committee requirements.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14037Informed consent form    Informed consent will be collected electronically ... [More Details] 383076-(Uploaded-10-11-2021-12-29-09)-Study-related document.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.