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Trial registered on ANZCTR


Registration number
ACTRN12612000478819
Ethics application status
Approved
Date submitted
16/03/2012
Date registered
1/05/2012
Date last updated
12/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of night milk versus day milk in insomnia
Scientific title
Randomised double blind cross over study of night milk versus day milk on insomnia symptoms in adults aged 25-60 years
Secondary ID [1] 273516 0
Nil
Universal Trial Number (UTN)
Trial acronym
MOOS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 279322 0
Condition category
Condition code
Neurological 279509 279509 0 0
Other neurological disorders
Mental Health 286288 286288 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Night milk: 30minutes prior to bed take product orally daily for 3 weeks. Night milk is from cows milked at night and contains milk protein (600mg/100g). Dose: 250ml (25g of total milk powder).
There will be a one week wash-out period before starting arm 2 of the study.
Intervention code [1] 283832 0
Treatment: Other
Comparator / control treatment
Day milk: 30minutes prior to bed take product orally daily for 3 weeks. Day milk is a product made from cows milked during the day and contains milk protein (600mg/100g). Dose: 250ml (25g of total milk powder).
Control group
Active

Outcomes
Primary outcome [1] 286074 0
Sleep onset latency, using EEG from overnight study and estimate over one week from actigraphy.
Timepoint [1] 286074 0
Week 3 of 3 week trial.SOL from EEG will be assess on one occasion only - day 21 and actigraphy from each night of week three.
Primary outcome [2] 286522 0
Subjective sleep quality. PROMIS Pittsburgh sleep quality index , Functional Outcomes of Sleep Questionnaire
Timepoint [2] 286522 0
Week 3 of 3 week trial. This will be assessed across every night of week 3.
Secondary outcome [1] 295075 0
Wake after sleep onset. This will be assessed using EEG during an overnight sleep study on night 21.
Timepoint [1] 295075 0
Week 3 of 3 week trial. It will be measured on one occasion - day 21.
Secondary outcome [2] 295076 0
PROMIS sleep disturbance questionnaire
Timepoint [2] 295076 0
week 3 of 3 week trial. This will be assess on each night of week 3.
Secondary outcome [3] 295077 0
PROMIS sleep related impairment questionnaire
Timepoint [3] 295077 0
week 3 of 3 week trial. This will be assessed on each night of week 3.

Eligibility
Key inclusion criteria
Sleep onset latency >30min
Adult 25-60 years
PSQI score >= 7
Minimum age
25 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other sleep disorders such as OSA, PLMS, narcolepsy
Taking prescription drugs that a) aid sleep b) promote weight loss c) alter mood d) prevent sleep
Allergies to dairy products
High consumer of caffeine
Shift worker

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)
Once a subject has met the enrolment criteria they will be allocated a treatment sequence using a closed urn randomisation of A/B or B/A-see below.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prospective urn randomisation using a (2,1) sdchedule was used. A container with two coloured paper clips was prepared. One clip was blindly withdrawn and its corresponding treated noted on a folded piece of paper in an opaque nevelope which wa then sealed. This was repeated until 20 envelopes are created.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3990 0
New Zealand
State/province [1] 3990 0

Funding & Sponsors
Funding source category [1] 284309 0
Commercial sector/Industry
Name [1] 284309 0
Synlait Milk Ltd
Address [1] 284309 0
1028 Heslerton Road, RD 13, Rakaia 7783
Canterbury
Country [1] 284309 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
DUNEDIN 9054
Country
New Zealand
Secondary sponsor category [1] 283253 0
None
Name [1] 283253 0
Address [1] 283253 0
Country [1] 283253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286273 0
Multi Region Ethics committee
Ethics committee address [1] 286273 0
C/- MOH
PO BOX 5013
Wellington 6145
Ethics committee country [1] 286273 0
New Zealand
Date submitted for ethics approval [1] 286273 0
21/11/2011
Approval date [1] 286273 0
14/02/2012
Ethics approval number [1] 286273 0
MEC/11/12/099

Summary
Brief summary
The study is designed to investigate whether night milk (from cows milked at night plus a milk protein) has an effect on insomnia symptoms compared to day milk (milk from cows milked during the day). Queries regarding the trial can be submitted to: Dr Angela Campbell, Department of Medicine University of Wellington p: + 6449208819 f: + 6449208861 e: wellsleep@paradise.net.nz
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33478 0
Dr Angela Campbell
Address 33478 0
Dept Medicine
University of Otago Wellington
PO Box 7343
23a Mein St
Newtown
Wellington 6035
New Zealand
Country 33478 0
New Zealand
Phone 33478 0
+64 4 9208819
Fax 33478 0
Email 33478 0
wellsleep@paradise.net.nz
Contact person for public queries
Name 16725 0
Dr Angela Campbell
Address 16725 0
Dept Medicine
University of Otago Wellington
PO Box 7343 Wellington 6242
Country 16725 0
New Zealand
Phone 16725 0
+64 4 9208819
Fax 16725 0
Email 16725 0
wellsleep@paradise.net.nz
Contact person for scientific queries
Name 7653 0
Dr Angela Campbell
Address 7653 0
Dept Medicine
University of Otago Wellington
PO Box 7343 Wellington 6242
Country 7653 0
New Zealand
Phone 7653 0
+64 4 9208819
Fax 7653 0
Email 7653 0
wellsleep@paradise.net.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary