The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorStudySetGo
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Magnesium and melatonin based multi-ingredient dietary supplementation
Dietary supplementThe active intervention is a commercially available multi-ingredient dietary supplement, supplied by Imagine Biolabs LLC (trading as SaltWrap) and sold under the brand name Mag R\&R. The dose is up to 3 capsules per day taken 30 minutes before bedtime with water. The product is stored at room temperature.
Placebo
Other interventionThe placebo is manufactured by the same manufacturer that produces the active product (Vitaquest International, New Jersey, USA). The placebo is visually similar to the active product and will be packaged in the same plain bottles as the active intervention to maintain the blind. The placebo dose is up to 3 capsules per day taken with water. Packaging is managed by Vitaquest International.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Magnesium and melatonin based multi-ingredient dietary supplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality over the past month. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame
From enrollment to the end of treatment at 6 weeksSecondary outcomes
1
36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a self-reported questionnaire assessing health-related quality of life across eight domains. Scale scores range from 0 to 100, with higher scores indicating better health.
Time frame
From enrollment to the end of treatment at 6 weeks2
REM sleep assessed via Oura Ring wearable
Time frame
From enrollment to the end of treatment at 6 weeks Source ClinicalTrials.gov