Clinical trial NCT05825209: Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity
Official title: Food-Grown Magnesium Supplement on Sleep Quality/Quantity in a Healthy Adult Population: A Double Blind Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

  1. 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.
  2. 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)

Primary outcomes:
measure: Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
timeFrame: Baseline, week 1, week 4 and week 8
measure: Change in sleep quantity by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
timeFrame: Baseline, week 1, week 4 and week 8
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline and week 8
measure: Change in height in anthropometry measurements
timeFrame: Baseline and week 8
measure: Change in weight in anthropometry measurements
timeFrame: Baseline and week 8
measure: Change in BMI in anthropometry measurements
timeFrame: Baseline and week 8
measure: Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, week 4 and week 8
measure: Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M).
timeFrame: Baseline, week 1, week 4 and week 8
measure: Change in sleep onset time as assessed by wrist actigraphy
timeFrame: Baseline, week 1, week 4 and week 8
measure: Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, week 4 and week 8.
measure: Change in sleep pattern disturbance as assessed by wrist actigraphy
timeFrame: Baseline, week 1, week 4 and week 8
measure: Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, week 4 and week 8
measure: Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire
timeFrame: Baseline, week 4 and week 8
measure: Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Baseline and week 8
Other outcomes:
measure: Adverse Events self-reported by participants
timeFrame: 8 week period from enrolment to participant conclusion
measure: Change in medication use
timeFrame: Baseline, week 1, week 4 and week 8
measure: Investigational product dosing compliance
timeFrame: Baseline, week 1, week 4 and week 8
Locations:
city: Brisbane
country: Australia
facility: RDC Global Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: