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

RecruitingNAAges 40 Years - 75 YearsAllStudySetGo
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In plain words

What the trial is, and whether it could suit you

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. Participan

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults aged 40-75 years * Self-reported poor sleep quality (PSQI \>5) at screening * Self-reported nocturnal leg cramp averaging โ‰ฅ4 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
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What it tests

  • Magnesium and melatonin based multi-ingredient dietary supplementation
  • Placebo
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Where

7 sites
StudySetGo - Decentralised (Remote) Site
Birmingham, United States
StudySetGo - Decentralised (Remote) Site
Little Rock, United States
StudySetGo Decentralised team
Palm Beach Gardens, United States
StudySetGo - Decentralised (Remote) Site
Atlanta, United States
StudySetGo - Decentralised (Remote) Site
Charlotte, United States
StudySetGo - Decentralised (Remote) Site
Charleston, United States
StudySetGo - Decentralised (Remote) Site
Nashville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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