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.

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).

Study Overview

• Status: Recruiting
• Conditions: Poor Sleep Quality; Leg Cramps, Nocturnal
• Intervention / Treatment: Dietary supplement: Magnesium and melatonin based multi-ingredient dietary supplementation; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom Jameson, PhD; Phone Number: +447794865520; Email: tom.jameson@studysetgo.com
• Study Contact Backup: Name: Christopher Koscien, PhD; Phone Number: +44 7847617414; Email: chris.koscien@studysetgo.com

Study Locations

• United States
  • Florida
    • Palm Beach Gardens, Florida, United States, 33418
      • Recruiting
      • StudySetGo Decentralised team
      • Contact: Tom Jameson; Phone Number: +44 7794865520; Email: tom.jameson@studysetgo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; The 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.
Experimental: Magnesium and melatonin based multi-ingredient dietary supplement	Dietary supplement: Magnesium and melatonin based multi-ingredient dietary supplementation; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 6 weeks
REM sleep assessed via Oura Ring wearable		From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: StudySetGo

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias; Sleep-Wake Transition Disorders; Inorganic Chemicals; Elements; Metals, Light; Metals; Metals, Alkaline Earth; Magnesium
• Other Study ID Numbers: SSG-26-001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No