Food-Grown Magnesium Supplement on Sleep Quality/Quantity in a Healthy Adult Population: A Double Blind Randomized Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Food-Grown Magnesium
Food-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.
干预措施: Food-Grown Magnesium (Drug)
Microcrystalline cellulose
Microcrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.
干预措施: Microcrystalline cellulose (Drug)
结局指标
主要结局
Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
时间窗: Baseline, week 1, week 4 and week 8
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'
Change in sleep quantity by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
时间窗: Baseline, week 1, week 4 and week 8
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).
次要结局
- Change in weight in anthropometry measurements(Baseline and week 8)
- Change in BMI in anthropometry measurements(Baseline and week 8)
- Change in quality of life(Baseline and week 8)
- Change in height in anthropometry measurements(Baseline 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).(Baseline, week 1, week 4 and week 8)
- Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, week 4 and week 8)
- Change in sleep onset time as assessed by wrist actigraphy(Baseline, week 1, week 4 and week 8)
- Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, week 4 and week 8.)
- Change in sleep pattern disturbance as assessed by wrist actigraphy(Baseline, week 1, week 4 and week 8)
- Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)(Baseline, week 4 and week 8)
- Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire(Baseline, week 4 and week 8)
- Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21)(Baseline and week 8)