Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001215516p
Ethics application status
Not yet submitted
Date submitted
18/09/2024
Date registered
3/10/2024
Date last updated
3/10/2024
Date data sharing statement initially provided
3/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of evening egg protein consumption on sleep during perimenopause
Scientific title
Effect of evening egg protein consumption on sleep latency during perimenopause
Secondary ID [1] 312940 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EggPro-Sleep PM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perimenopause 335108 0
Condition category
Condition code
Reproductive Health and Childbirth 331609 331609 0 0
Menstruation and menopause
Diet and Nutrition 331610 331610 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A counterbalanced crossover design has been selected for this study. Through a crossover design, each participant will receive a sleep hygiene training session on the first week of the study, consisting of a single 1-hour online webinar over Zoom with a sleep educator. During this session, the following topics will be discussed (i.e., arranging a good sleep environment and habits, reducing emotional stress, controlling diet, alcohol consumption and tobacco use and regular exercise) and a sleep hygiene strategy developed. This sleep hygiene strategy will be maintained throughout the duration of the study, and self-reported and monitored using an EEG headband device (SomFit Compumedics) (~19 days at different stages of the study) and by completing the Pittsburgh Sleep Quality Index (PSQI) questionnaire (6 times during the study) and a daily sleep diary.
This will be followed by two 3-week intervention periods, one in which they consume eggs two hours after dinner/evening meal (intervention) or in their morning two hours after breakfast (comparator) while continuing their usual diet. The eggs will be consumed as two units per day from the participant’s home, in the form of whole eggs and/or simple preparations with them (e.g., poached, microwaved, fried) with a wash-out period of minimum 7 days between both arms of the study (intervention or comparator).
The dietary intervention won’t be personalised but standardised for all participants, with their usual diet being followed throughout the study period.
Participants will get some recipes and ideas to prepare these eggs to improve study adherence. Study adherence will be tracked daily using a self-completed tally and monitored through weekly food records, which will be assessed by a nutritionist/dietitian.
Intervention code [1] 329526 0
Treatment: Other
Comparator / control treatment
A comparison between eggs consumption as a morning (comparator) OR evening (intervention) snack will be conducted as part of this study.
Control group
Active

Outcomes
Primary outcome [1] 339395 0
Sleep Latency
Timepoint [1] 339395 0
Days 1-3, 8-11, 25-28, 36-39 and 53-56 post-commencement of intervention
Primary outcome [2] 339529 0
Sleep duration
Timepoint [2] 339529 0
Days 1-3, 8-11, 25-28, 36-39 and 53-56 post-commencement of intervention
Secondary outcome [1] 439760 0
Perimenopausal Symptoms
Timepoint [1] 439760 0
Baseline, days 1, 8, 28, 36 and 56 post-commencement of intervention
Secondary outcome [2] 439761 0
Eggs Acceptability
Timepoint [2] 439761 0
Days 29 and 57 post-commencement of intervention
Secondary outcome [3] 439762 0
Melatonin bioavailability
Timepoint [3] 439762 0
Days 1, 9, 29, 37 and 57 post-commencement of intervention
Secondary outcome [4] 439763 0
Appetite
Timepoint [4] 439763 0
Days 1, 8, 18. 24, 28, 36, 46 and 56 post-commencement of intervention
Secondary outcome [5] 439764 0
Body Composition
Timepoint [5] 439764 0
Baseline (week 0) and end of intervention (week 9)

Eligibility
Key inclusion criteria
Participants must be female healthy perimenopausal adults (greater than or equal to 40-55 years of age), naturally menstruating and/or stable users of hormonal replacement therapy (HRT) for more than 3 months, with current perimenopause symptoms and/or menstrual cycle disturbances (greater than 1 year). Further, participants will be screened using the Pittsburgh Sleep Quality Index (PSQI), and those with a global PSQI score above 5 will be eligible. These scores coincide with mild or above sleep difficulty and poor-quality sleep, which are the targeted participants for this study. Participants must live in Melbourne, Australia, and be willing to travel to Deakin Burwood Campus on 3 separate occasions.
Minimum age
40 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if diagnosed with primary ovarian failure, pregnant or lactating; with fluctuating bedtimes or diagnosed with any existing sleeping disorders such as insomnia or consuming any antidepressant, sleep medication or nutraceutical or herbal sleeping aids such as melatonin gummies, chamomile or any other herbs influencing exogenous melatonin. Participants must not be current smokers, with excessive alcohol consumption (>17 standard drinks per week), be high caffeine users (e.g., >5 mg/kg/day, equivalent to >2x 100 mL espressos per day for a 70Kg average person), with allergy to eggs, or consuming regularly more than 3 whole eggs per week (average over the past 3 months). The exclusion criteria relate to confounding influences on the circadian rhythm, sleep and/or sensibility to eggs consumption.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317375 0
Commercial sector/Industry
Name [1] 317375 0
Australian Eggs Limited
Country [1] 317375 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 319720 0
None
Name [1] 319720 0
Address [1] 319720 0
Country [1] 319720 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316104 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 316104 0
Ethics committee country [1] 316104 0
Australia
Date submitted for ethics approval [1] 316104 0
21/10/2024
Approval date [1] 316104 0
Ethics approval number [1] 316104 0

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

Contacts
Principal investigator
Name 136794 0
Dr David Lee Hamilton
Address 136794 0
Geelong Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, Victoria 3216
Country 136794 0
Australia
Phone 136794 0
+61 3 924 45207
Fax 136794 0
Email 136794 0
[email protected]
Contact person for public queries
Name 136795 0
David Lee Hamilton
Address 136795 0
Geelong Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, Victoria 3216
Country 136795 0
Australia
Phone 136795 0
+61 3 924 45207
Fax 136795 0
Email 136795 0
[email protected]
Contact person for scientific queries
Name 136796 0
David Lee Hamilton
Address 136796 0
Geelong Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, Victoria 3216
Country 136796 0
Australia
Phone 136796 0
+61 3 924 45207
Fax 136796 0
Email 136796 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
Due to the Industry Partnership in place and to guarantee confidentiality of the participants, individual participant's data for this trial won't be available.


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.