Poor Sleep QualityMISITNCT07651514
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
A study testing Magnesium and melatonin based multi-ingredient dietary supplementation in people with Poor Sleep Quality and Leg Cramps, Nocturnal, run by StudySetGo at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Sleep Quality, Leg Cramps, Nocturnal
- What is being tested?
- Magnesium and melatonin based multi-ingredient dietary supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2026to 10 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
StudySetGo Decentralised team
Palm Beach Gardens, Florida, 33418
Tom Jameson, +44 7794865520, tom.jameson@studysetgo.com
About this study
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.
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.
Read more
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).
- Conditions
- Poor Sleep Quality, Leg Cramps, Nocturnal
- Being tested
- Magnesium and melatonin based multi-ingredient dietary supplementation, Placebo
- Medical subject headings
- Sleep-Wake Transition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium and melatonin based multi-ingredient dietary supplementationDietary 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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Magnesium and melatonin based multi-ingredient dietary supplement | Experimental | Not described Receives: Dietary Supplement: Magnesium and melatonin based multi-ingredient dietary supplementation |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (2)
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.
Measured: From enrollment to the end of treatment at 6 weeks
REM sleep assessed via Oura Ring wearable
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StudySetGo
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651514
- Sponsor's protocol ID
- SSG-26-001-001
- Acronym
- MISIT
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided