Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity
NCT ID: NCT05825209
Last Updated: 2023-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2023-04-06
2023-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Food-Grown Magnesium
Food-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.
Food-Grown Magnesium
1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)
Microcrystalline cellulose
Microcrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.
Microcrystalline cellulose
1 daily dose of 2 capsules containing microcrystalline cellulose
Interventions
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Food-Grown Magnesium
1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)
Microcrystalline cellulose
1 daily dose of 2 capsules containing microcrystalline cellulose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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RDC Clinical Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Amanda Rao, PhD
Role: PRINCIPAL_INVESTIGATOR
RDC Clinical Pty Ltd
Locations
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RDC Global Pty Ltd
Brisbane, Queensland, Australia
Countries
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Other Identifiers
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MAGSLE
Identifier Type: -
Identifier Source: org_study_id
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