Research has shown that there is a close relationship between sleep and diet. It has been shown that a vitamin and mineral rich diet is related to better sleep. This relationship can go both ways as poor sleep can also impact on your diet. Specifically, low magnesium levels have been associated with insomnia and adding magnesium to the diet of an individual with insomnia can help with their symptoms. Whilst this is known about insomnia, far less is known about the impact of magnesium on general sleep health. In other words, people who don't have a sleep disorder but could be sleeping better generally. The aim of this study is to determine whether supplementing with Magnesium in those people who are deficient over a period of 8 weeks improves overall sleep health.
This study will be an open label trial 60 participants will consume 250mg of magnesium supplement daily over a 56-day period. During their participation in this study participants will visit the Sleep Lab on three (3) occasions to pick up or drop off an actiwatch and receive the supplement (visit 2). Informed consent will be obtained online and be followed by an online demographic screener, sleep screener (SDSCL-25), chronotype screener (MCTQ, HO), standard health screener and 3-day food diary. On visit 1 participants will receive an actiwatch and undergo a 7 night sleep monitoring period where remote assessment of sleep via Actigraphy watch will be completed (baseline). On visit 2, 7-10 days following visit 1, participants will arrive at the lab return their actigraphy watch and be provided with a new actiwatch and the supplement. Participants will provide a detailed recall of their diet in the past 24 hours and complete a Gastrointestinal symptoms questionnaire - The questionnaire asks 11 questions, plus a 12th open-ended question, about gastrointestinal experiences, with 5 possible ratings: 'not at all' (score of 0), 'A little' (score of 1), 'a moderate amount' (score of 2), 'quite a lot' (score of 3) and 'a severe amount' (score of 4). Scores can range between 0-44 with a higher score indicating a more negative experience of symptoms. On visit 3, 56 days following, visit 2, participants will return the actiwatch and any supplements left over then be debriefed and participant payment details will be taken to facilitate their participant payment (£50). Note: Timings given here are approximates for illustrative purposes and may be subject to change due to unexpected delays.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
65
Participants will consume 250 mg of magnesium once a day preferably with a meal
Northumbria Sleep Research, Northumbria University
Newcastle, United Kingdom
Actigraphy - Sleep onset latency
recorded minutes taken from intention to sleep to sleep initiation
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary -Sleep Latency
how long, in minutes, the individual felt it took them to fall asleep after intending to sleep
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - total sleep time
recorded minutes asleep over entire sleep period
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary - total sleep time
how long, in minutes, the individual reports being asleep during the night between initiation and termination of sleep, accounting for nocturnal wake periods
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Wake after sleep onset (WASO)
recorded minutes awake during the entire sleep period following sleep onset
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary - Wake After Sleep Onset (WASO)
how long, in minutes, the individual reports being awake during the night after sleep initiation
Time frame: Change from baseline following 56 days of supplement consumption
Actigraphy - Sleep efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Time frame: Change from baseline following 56 days of supplement consumption
Sleep Diary - Sleep efficiency
Total Sleep Time divided by Time in Bed x 100, expressed as a percentage
Time frame: Change from baseline following 56 days of supplement consumption
Dietary assessment- 7 day dietary recall
Participants will complete 7 day dietary recall questionnaire
Time frame: Change from baseline following 56 days of supplement consumption
Gastrointestinal symptoms questionnaire
When completing the assessment, participants will answer in relation to their experiences in the previous 7 days. The questionnaire asks 11 questions, plus a 12th open-ended question, about gastrointestinal experiences, with 5 possible ratings; 'not at all' (score of 0), 'A little' (score of 1), 'a moderate amount' (score of 2), 'quite a lot' (score of 3) and 'a severe amount' (score of 4). Scores can range between 0-44 with a higher score indicating a more negative experience of symptoms
Time frame: Change from baseline following 56 days of supplement consumption
Generalized Anxiety Disorder 7- Item Scale scores (GAD-7)
The GAD-7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. It contains 7 items with answers ranging from "Not at all" to "Nearly every day".
Time frame: Change from baseline following 56 days of supplement consumption
Patient Health Questionnaire (PHQ9)
The PHQ9 will screen for depression symptoms. It is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: It incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.
Time frame: Change from baseline following 56 days of supplement consumption
Munich Chronotype Questionnaire (MCTQ)
Self-rated scale to assess individual phase of entrainment on work and work-free days, developed in ages 6 to \> 65 years; tool to collect primary sleep times, such as bed- and rise-times, plus the clock time of becoming fully awake as well as sleep latency and inertia, in addition to other time points and rate themselves as one of the seven chronotypes.
Time frame: Change from baseline following 56 days of supplement consumption
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