None listed
Conditions
Brief summary
This study aims to explore whether consuming eggs in the evening can improve sleep and overall health for perimenopausal women. Perimenopause often leads to sleep disturbances due to hormonal changes, which can impact anxiety, appetite regulation, and overall well-being. Eggs contain nutrients like protein and melatonin that may promote better sleep. The study's primary goal is to determine if evening egg consumption, along with sleep hygiene education, can enhance sleep duration. Secondary aims include reducing perimenopausal symptoms, assessing the acceptability of evening egg consumption, evaluating changes in urinary melatonin, appetite responses and body composition.
Interventions
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 h
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed