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

Part of paid clinical trials in Palm Beach Gardens, Florida.

Sponsor
StudySetGo
Study ID
NCT07651514
Status
Recruiting
Apply to this trial

Conditions

  • Leg Cramps, Nocturnal
  • Poor Sleep Quality

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Magnesium and melatonin based multi-ingredient dietary supplementation — DIETARY_SUPPLEMENT
    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.
  • Placebo — OTHER
    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.

Study Details

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).

Key Dates

Start date
Jun 10, 2026
Status verified
Jun 2026
Primary completion
Sep 10, 2026
Completion
Sep 10, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Magnesium and melatonin based multi-ingredient dietary supplement
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
StudySetGo Decentralised teamPalm Beach GardensFlorida33418
Tom Jameson
[email protected]
+44 7794865520

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StudySetGo Decentralised team· Palm Beach Gardens, FL

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