The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps

Official title

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.

Overview

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).

Interventions

• 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.
• 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.

Primary outcome measures

• Pittsburgh Sleep Quality Index (PSQI) [Time frame: From enrollment to the end of treatment at 6 weeks]

Secondary outcome measures (2)

• 36-Item Short Form Health Survey (SF-36) [Time frame: From enrollment to the end of treatment at 6 weeks]
• REM sleep assessed via Oura Ring wearable [Time frame: From enrollment to the end of treatment at 6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• StudySetGo Decentralised team — Palm Beach Gardens

Identifiers

NCT: NCT07651514 · SSG-26-001-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗