The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps

Inclusion criteria

• Adults aged 40-75 years
• Self-reported poor sleep quality (PSQI >5) at screening
• Self-reported nocturnal leg cramp averaging ≥4 episodes per fortnight at screening
• Capacity to understand and provide electronic informed consent
• Willing to wear an Oura Ring wearable device continuously throughout the study period
• Access to a smartphone/tablet with iOS 15 or higher and Android 9 or higher and willing to install and use the Oura and Trialflare applications
• Be a resident of and permanently living in Florida with no planned travel across more than one time zone for at least 1 night during the study period

Exclusion criteria

• Current or recent (within 4 weeks of randomisation) use of melatonin, magnesium, or other supplements specifically taken for sleep or leg cramps or listed as an ingredient of the intervention supplement.
• Current use of any prescription medication
• Diagnosed sleep disorder (e.g. obstructive sleep apnoea, restless legs syndrome, insomnia disorder)
• Known or suspected secondary cause of nocturnal leg cramps (e.g. peripheral vascular disease, neurological condition, renal impairment, thyroid disorder)
• Any current or prior diagnosis of:
• Cancer or malignancy of any kind (prior malignancy is not exclusionary if the participant is in confirmed remission and has completed all treatment)
• Cardiovascular disease (e.g. hypertension, coronary artery disease, heart failure, arrhythmia, stroke, peripheral vascular disease)
• Autoimmune disorder (e.g. rheumatoid arthritis, lupus, multiple sclerosis)
• Gastrointestinal disorder (e.g. IBS, malabsorption syndromes)
• Neurological disorder (e.g. epilepsy, Parkinson's disease, dementia)
• Hepatic or renal impairment
• Diabetes mellitus (type 1 or type 2)
• Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
• Myasthenia Gravis
• Known hypersensitivity or allergy to any ingredient in the active or placebo product
• Rotating shift work or irregular sleep patterns
• Current participation in another interventional clinical trial
• Inability to comply with study procedures or remote visit schedule
• Breastfeeding, pregnant, or planning to become pregnant during the study period