Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity

RDC Clinical

Status and phase: Completed; Phase 3

Conditions: Sleep

Treatments: Drug: Microcrystalline cellulose; Drug: Food-Grown Magnesium

Study type: Interventional

Funder types: Industry

Identifiers

NCT05825209

MAGSLE

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Food-Grown Magnesium

Active Comparator group

Description:

Food-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.

Treatment:

Drug: Food-Grown Magnesium

Microcrystalline cellulose

Placebo Comparator group

Description:

Microcrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.

Treatment:

Drug: Microcrystalline cellulose