No phaseRecruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps (MISIT)
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.
- Sponsor
- StudySetGo (Research network)
- Enrolment
- 50 planned
- Conditions
- Poor Sleep Quality; Leg Cramps, Nocturnal
- Interventions
- Magnesium and melatonin based multi-ingredient dietary supplementation; Placebo
- Ages
- adults, older adults
- Registry
- NCT07651514
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Pittsburgh Sleep Quality Index (PSQI)
History
Primary completion expected
Last registry update
Started
Registered