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The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
An Investigation Into the Effect of a Daily Magnesium and Melatonin Based Multi-Ingredient Dietary Supplement on Sleep Quality in Individuals With Self-Reported Nighttime Leg Cramps.
Who can join
Ages 40 to 75 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve.
Purpose: This study will investigate whether a multi-ingredient nutritional supplement containing magnesium and melatonin can improve sleep quality in adults who experience disrupted sleep due to nighttime leg cramps.
What participation involves: Participation lasts 8 weeks. Participants will be randomly assigned to take either the nutritional supplement or a placebo (inactive look-alike) every night before bed for 6 weeks. Participants will wear an Oura Ring wearable device on one finger continuously for 8 weeks throughout the study and complete short questionnaires using a smartphone app. The Oura Ring and study supplement will be sent to the participant's home address. Participants will never need to travel to a research centre; all contact with the research team will be by video call, phone, messaging, or email.
How long: Total involvement will be 8 weeks, made up of a 2-week baseline period and a 6-week supplementation period. Each day, participants will complete a short app-based questionnaire (approximately 1 minute). At the end of weeks 2, 4, 6, and 8, participants will complete additional app-based questionnaires (approximately 10 minutes).
What is being tested
- Magnesium and melatonin based multi-ingredient dietary supplementation (dietary supplement)
- Placebo (other)
Sponsor: StudySetGo · Participants: 50 · Started: Jun 10, 2026
Contact the study team
- Tom Jameson, PhD · Phone: +447794865520
- Christopher Koscien, PhD · Phone: +44 7847617414
Official record on ClinicalTrials.gov — NCT07651514
Locations in the U.S.
| Florida | StudySetGo Decentralised team, Palm Beach Gardens |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.