The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Eligible age
40–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this 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).
Sponsor: StudySetGo
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
Palm Beach Gardens
Source: ClinicalTrials.gov · NCT07651514 · last updated 2026-06-16