Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000088549
Ethics application status
Approved
Date submitted
5/12/2023
Date registered
1/02/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
1/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain & Body Protein Powder and Sleep in Older Adults
Scientific title
Acute and chronic effects of the Brain & Body Protein Powder on sleep in healthy older adults
Secondary ID [1] 311116 0
Nil known
Universal Trial Number (UTN)
U1111-1298-5342
Trial acronym
SAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 332270 0
Cognitive function 332271 0
Psychological wellness 332272 0
Condition category
Condition code
Mental Health 328984 328984 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 328985 328985 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
Brain & Body Protein Powder
Participants will be required to consume 1 x 30g serve of Brain & Body Protein Powder per day. Each serve is to be mixed with around 200ml water and consumed 90 minutes prior to bedtime. Participants consume the intervention daily for 7 days.

Compliance will be monitored throughout the study. Participants will be assisted with this process through the completion of a consumption calendar that requires them to mark off each serving at time of its consumption. Participants who consume less than 80% of the required product throughout the duration of the study (equal to more than 1 missed serve) will be excluded from final analysis.
Intervention code [1] 327564 0
Treatment: Other
Comparator / control treatment
The trial intervention will be compared to a rice-starch placebo control. The active and control intervention products will be packaged in identical containers. Participants will be required to consume 1 x 30g serve of powder mixed with 200ml water per day 90 minutes prior to bedtime.
Details of interventions found above in description of interventions (Arm 1; Arm 2)
Control group
Placebo

Outcomes
Primary outcome [1] 336780 0
Subjective sleep quality
Timepoint [1] 336780 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [1] 429659 0
Changes in brain function
Timepoint [1] 429659 0
Acute – same day as first dose of study treatment and on day 8 (7 days after first dose of study treatment)
Secondary outcome [2] 429660 0
Brain activity during n-back task
Timepoint [2] 429660 0
Acute – same day as first dose of study treatment, after dosage.
Secondary outcome [3] 429661 0
Resting state brain activity
Timepoint [3] 429661 0
Acute – same day as first dose of study treatment, after dosage.
Secondary outcome [4] 429662 0
Mood
Timepoint [4] 429662 0
Acute – same day as first dose of study treatment, after dosage.
Secondary outcome [5] 429663 0
Vitality
Timepoint [5] 429663 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [6] 429664 0
Subjective sleep quality
Timepoint [6] 429664 0
Each day of the study following the baseline session (i.e., starting from Day 2), in the morning after waking
Secondary outcome [7] 429665 0
Levels of neurotransmitters measured in blood
Timepoint [7] 429665 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [8] 429666 0
Levels of phospholipids measured in blood
Timepoint [8] 429666 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [9] 429667 0
Levels of free amino acids (tryptophan) measured in blood
Timepoint [9] 429667 0
Acute - same day as first dose of study treatment after dosage and on day 8 (7 days after first dose of study treatment)
Secondary outcome [10] 434139 0
Subjective sleep quality
Timepoint [10] 434139 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [11] 434140 0
Subjective sleep quality
Timepoint [11] 434140 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [12] 434141 0
Subjective Sleep Quality
Timepoint [12] 434141 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [13] 434142 0
Subjective Sleep Quality
Timepoint [13] 434142 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [14] 434143 0
Subjective sleep quality
Timepoint [14] 434143 0
On day 8 (7 days after first dose of study treatment)
Secondary outcome [15] 434144 0
Subjective sleep quality
Timepoint [15] 434144 0
On day 8 (7 days after first dose of study treatment)

Eligibility
Key inclusion criteria
1. Aged 55 to 64 years of age (inclusive) at phone screen
2. Self-reported answer of yes to the following: “Do you feel as though you have poor sleep
quality?”
3. BMI equal to or more than 18.5 or equal to or less than 35 at time of phone screen
4. Willing and able to provide informed consent
5. Access to a personal (i.e., not shared) and valid email address
Minimum age
55 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous adverse reaction to milk or dairy proteins
2. Known allergy to rice, soy or soy lecithin
3. Current or recent participation, within the last 6 months, in any other clinical trial involving the administration of an active intervention for any purpose.
4. Current or previous sleep disorder diagnosis (e.g., sleep apnoea, insomnia)
5. Undiagnosed sleep apnoea (positive score in 2 or more categories of the Berlin Questionnaire)
6. Currently undergoing treatment to improve sleep (including psychotherapy and/or medication, e.g., Restavit, melatonin)
7. Currently engaged in ongoing shift work (i.e., any shift work undertaken in the last month)
8. Recent (approximately 2 weeks) travel across time zones/jetlag
9. Score of equal to or less than 11 on the MoCA-5min
10. Self-reported history of events that impact cognitive function defined as: concussion or brain injury requiring hospitalisation, transient ischemic attacks (mini-stroke), stroke, heart attack, coronary artery bypass surgery, or open-heart surgery.
11. Known history of Intellectual Disability or other developmental disorder (e.g., language disorder, ADHD, Autism)
12. A mental health condition that is being actively treated either pharmacologically or by a licensed mental-health professional (e.g., major depressive disorder, PTSD)
13. Diagnosed neurological disease including dementia (any type), Parkinsons Disease, Amyotrophic Lateral Sclerosis, Motor-neuron Disease, hippocampal damage, or Huntingtons Disease
14. Known type 1 or 2 Diabetes
15. Known digestive disorder diagnosis (e.g., GERD, IBS)
16. Blood pressure systolic more than 160 mmHg and diastolic more than 100 mmHg
17. Recent (i.e., in the last 3 months) medication use related to or likely to affect sleep, cognition, mood or serotonin levels, or medication which is not recommended to be used with tryptophan
18. Current smoker/vaper (or history of smoking including within last 12 months)
19. Recent (~6-month) use of illicit or psychoactive drugs
20. Individuals living with children under 12 months of age
21. Needle phobia or fainting due to fear of needles
22. Alcohol consumption more than 7 standard drinks per week
23. Known eosinophilia or liver/kidney diseases
24. Known carcinoid syndrome

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque packages will be used to conceal allocation. Study staff will be blinded to group allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be assigned to interventions using block randomisation. The randomisation scheme will be computer generated.
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
We performed a repeated measures power analysis for a between factors effect to determine the minimum sample size required to detect a medium-to-large effect of the current intervention on LSEQ QoS scores (Effect size F(v)= .50; alpha = .05; beta=.80; r=.60). The minimum number of participants required to detect this effect is n=34. Therefore, we aim to enrol n=40 participants allowing for 15-20% attrition to achieve this number at study endpoint
There are no planned interim analyses of any study outcomes. It is envisaged that analysis will focus on generalised linear mixed models. Outcomes will be assessed at the Intention To Treat level, with sensitivity models conducted using the per-protocol sample. All primary and secondary outcomes will be compared between the study groups. The primary analyses will involve 2-way comparisons between the dairy product group and the placebo control group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/05/2024
Actual
5/06/2024
Date of last participant enrolment
Anticipated
19/07/2024
Actual
Date of last data collection
Anticipated
26/07/2024
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 41748 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 315374 0
Commercial sector/Industry
Name [1] 315374 0
Fonterra
Country [1] 315374 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra
Address
Fonterra Research and Development Centre, Dairy Farm Rd, Fitzherbert, Palmerston North, 4472 New Zealand.
Country
New Zealand
Secondary sponsor category [1] 317435 0
Government body
Name [1] 317435 0
CSIRO (Commonwealth Scientific and Industrial Research Organisation)
Address [1] 317435 0
SAHMRI (South Australian Health and Medical Research Institute), North Terrace, Adelaide, South Australia 5000
Country [1] 317435 0
Australia
Other collaborator category [1] 282889 0
University
Name [1] 282889 0
University of Adelaide
Address [1] 282889 0
North Terrace, Adelaide, SA, 5005
Country [1] 282889 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314291 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [1] 314291 0
Ethics committee country [1] 314291 0
Australia
Date submitted for ethics approval [1] 314291 0
04/04/2023
Approval date [1] 314291 0
20/10/2023
Ethics approval number [1] 314291 0
2023_018_HREC

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

Contacts
Principal investigator
Name 131082 0
Dr Ian Zajac
Address 131082 0
CSIRO; PO Box 10041, Adelaide BC, SA, 5000 Australia
Country 131082 0
Australia
Phone 131082 0
+61 8 8303 8875
Fax 131082 0
Email 131082 0
[email protected]
Contact person for public queries
Name 131083 0
Ian Zajac
Address 131083 0
CSIRO; PO Box 10041, Adelaide BC, SA, 5000 Australia
Country 131083 0
Australia
Phone 131083 0
+61 8 8303 8875
Fax 131083 0
Email 131083 0
[email protected]
Contact person for scientific queries
Name 131084 0
Ian Zajac
Address 131084 0
CSIRO; PO Box 10041, Adelaide BC, SA, 5000 Australia
Country 131084 0
Australia
Phone 131084 0
+61 8 8303 8875
Fax 131084 0
Email 131084 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
No IPD sharing has been approved under the ethics approval for this study


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.