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Trials / Active Not Recruiting

Active Not RecruitingNCT07359612

Improving Sleep Health Through Magnesium Supplementation

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
65 (estimated)
Sponsor
Northumbria University · Academic / Other
Sex
All
Age
18 Years – 39 Years
Healthy volunteers
Accepted

Summary

Research has shown that there is a close relationship between sleep and diet. It has been shown that a vitamin and mineral rich diet is related to better sleep. This relationship can go both ways as poor sleep can also impact on your diet. Specifically, low magnesium levels have been associated with insomnia and adding magnesium to the diet of an individual with insomnia can help with their symptoms. Whilst this is known about insomnia, far less is known about the impact of magnesium on general sleep health. In other words, people who don't have a sleep disorder but could be sleeping better generally. The aim of this study is to determine whether supplementing with Magnesium in those people who are deficient over a period of 8 weeks improves overall sleep health.

Detailed description

This study will be an open label trial 60 participants will consume 250mg of magnesium supplement daily over a 56-day period. During their participation in this study participants will visit the Sleep Lab on three (3) occasions to pick up or drop off an actiwatch and receive the supplement (visit 2). Informed consent will be obtained online and be followed by an online demographic screener, sleep screener (SDSCL-25), chronotype screener (MCTQ, HO), standard health screener and 3-day food diary. On visit 1 participants will receive an actiwatch and undergo a 7 night sleep monitoring period where remote assessment of sleep via Actigraphy watch will be completed (baseline). On visit 2, 7-10 days following visit 1, participants will arrive at the lab return their actigraphy watch and be provided with a new actiwatch and the supplement. Participants will provide a detailed recall of their diet in the past 24 hours and complete a Gastrointestinal symptoms questionnaire - The questionnaire asks 11 questions, plus a 12th open-ended question, about gastrointestinal experiences, with 5 possible ratings: 'not at all' (score of 0), 'A little' (score of 1), 'a moderate amount' (score of 2), 'quite a lot' (score of 3) and 'a severe amount' (score of 4). Scores can range between 0-44 with a higher score indicating a more negative experience of symptoms. On visit 3, 56 days following, visit 2, participants will return the actiwatch and any supplements left over then be debriefed and participant payment details will be taken to facilitate their participant payment (£50). Note: Timings given here are approximates for illustrative purposes and may be subject to change due to unexpected delays.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTMagnesium 250 mgParticipants will consume 250 mg of magnesium once a day preferably with a meal

Timeline

Start date
2023-02-15
Primary completion
2024-07-31
Completion
2026-12-01
First posted
2026-01-22
Last updated
2026-01-22

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT07359612. Inclusion in this directory is not an endorsement.