This is a double-blind randomised placebo-controlled trial to evaluate orally-dosed food-grown magnesium compared to placebo on improvement in sleep quality and quantity as well as quality of life in otherwise healthy participants aged 18 years and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)
1 daily dose of 2 capsules containing microcrystalline cellulose
RDC Global Pty Ltd
Brisbane, Queensland, Australia
Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M). Sleep quality is assessed by a 5 category rating from 'Very poor' to 'Very good'. Sleep quality is also assessed by a 5 category rating of the degree of rested state from 'Not at all rested' to "Very well-rested'
Time frame: Baseline, week 1, week 4 and week 8
Change in sleep quantity by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
Change in sleep quantity, as defined as the collective amount of sleep obtained in a given period, by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
Time frame: Baseline, week 1, week 4 and week 8
Change in quality of life
Change in quality of life as assessed by the Short Form 36 Health Survey Questionnaire (SF36) which consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Baseline and week 8
Change in height in anthropometry measurements
Height as measured by stadiometer in centimeters
Time frame: Baseline and week 8
Change in weight in anthropometry measurements
Weight as measured by digital scales in kilograms
Time frame: Baseline and week 8
Change in BMI in anthropometry measurements
Height and will be combined to report BMI in kg/m2
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Time frame: Baseline and week 8
Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: Baseline, week 4 and week 8
Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M).
Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M). Participants are asked "How long did it take you to fall asleep?"
Time frame: Baseline, week 1, week 4 and week 8
Change in sleep onset time as assessed by wrist actigraphy
Change in sleep onset time as assessed by wrist actigraphy which measures wrist movements to assess sleep or waking state.
Time frame: Baseline, week 1, week 4 and week 8
Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: Baseline, week 4 and week 8.
Change in sleep pattern disturbance as assessed by wrist actigraphy
Change in sleep pattern disturbance as assessed by wrist actigraphy which measures wrist movements to assess sleep or waking state.
Time frame: Baseline, week 1, week 4 and week 8
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) which is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. The ESS score (the sum of 8 item scores) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity or their 'daytime sleepiness'.
Time frame: Baseline, week 4 and week 8
Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire
Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire. Ten component scores are derived, each scored 0 (none) to 4 (very severe). The component scores are summed to produce a global score (range 0 to 40). Higher scores indicate more severe symptoms.
Time frame: Baseline, week 4 and week 8
Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21)
Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21) comprising 21 questions all with a rating scale from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). The total score represents overall distress (0 to 30), with higher scores indicating more severe distress or a greater number of symptoms.
Time frame: Baseline and week 8