Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Food-Grown Magnesium Supplement on Sleep Quality/Quantity in a Healthy Adult Population: A Double Blind Randomized Placebo-controlled Study

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Drug: Food-Grown Magnesium
* Drug: Microcrystalline cellulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years or older Otherwise healthy Disturbed sleeping pattern (defined as difficulty falling asleep, waking up during the sleep cycle or waking up too early and being unable to fall back to sleep) Able to provide informed consent Agree not to change current diet/exercise or not to use other medicines or supplements for sleep or anxiety other than the test product during entire study period. Agree not to participate in another clinical trial while enrolled in this trial Exclusion Criteria: Unstable or serious illness (e.g. serious mood disorders such as depression or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease, GIT conditions, heart conditions, diabetes, thyroid gland function) (1) History of renal function impairment Regular sleeping pattern Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy Receiving/prescribed sleep or anxiety medication/aid Sleep apnea Diagnosed or consistent gastrointestinal issues that disrupt sleep Active smokers, nicotine use, drug abuse Chronic past and/or current alcohol use (>14 alcoholic drinks week) Allergic to any of the ingredients in active or placebo formula People with serious mood disorders (such as depression, anxiety and bipolar disorder) will be excluded Those suffering from insomnia or have night-shift employment and unable to have a normal night's sleep (2) People suffering any neurological disorders such as MS Pregnant or lactating woman Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion Participants who have participated in any other clinical trial during the past 6 months Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis History of infection in the month prior to the study Regularly taking stimulants (e.g., coffee, caffeine supplements, caffeine containing beverages) 2 hours before bed Disturbed sleeping pattern caused by external factors (e.g., children, partner, noises) An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. Insomnia has been excluded as it is a significant health condition, and we are testing on otherwise healthy participants (as per TGA complementary medicine requirements)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Food-Grown Magnesium<br>Food-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep. | Drug: Food-Grown Magnesium<br>* 1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)<br>|
| Placebo Comparator: Microcrystalline cellulose<br>Microcrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep. | Drug: Microcrystalline cellulose<br>* 1 daily dose of 2 capsules containing microcrystalline cellulose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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' | 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). | Baseline, week 1, week 4 and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and week 8 | 
| Change in height in anthropometry measurements | Height as measured by stadiometer in centimeters | Baseline and week 8 | 
| Change in weight in anthropometry measurements | Weight as measured by digital scales in kilograms | Baseline and week 8 | 
| Change in BMI in anthropometry measurements | Height and will be combined to report BMI in kg/m2 | 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. | 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? | 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. | 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. | 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. | 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'. | 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. | 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. | Baseline and week 8 |