NCT07651514 The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
| NCT ID | NCT07651514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | StudySetGo |
| Condition | Poor Sleep Quality |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-10-10 |
| Primary Completion | 2027-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-10-10 with a primary completion date of 2027-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07651514 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Poor Sleep Quality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07651514 currently recruiting?
Yes, NCT07651514 is actively recruiting participants. Contact the research team at misit@studysetgo.com for enrollment information.
Where is the NCT07651514 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Palm Beach Gardens, United States, Atlanta, United States and 3 additional locations.
Who is sponsoring the NCT07651514 clinical trial?
NCT07651514 is sponsored by StudySetGo. The trial plans to enroll 50 participants.