Magnesium Supplementation for Sleep Improvement in Adults
Magnesium 250 mg
Other Study
Summary
Study start date: February 15, 2023
Actual date on which the first participant was enrolled.This study focuses on improving sleep health through the use of magnesium supplements. It involves 60 participants who experience sleep issues. The goal is to understand if magnesium can enhance sleep quality, addressing the need for better sleep solutions. Participants are required to consume a daily magnesium supplement of 250mg over a period of 56 days. During the study, participants visit a Sleep Lab three times. The first visit involves receiving an actiwatch, a device that monitors sleep patterns for seven nights. On the second visit, participants return the actiwatch, receive a new one, and get their magnesium supplement. They also complete a diet recall and a gastrointestinal symptoms questionnaire. The final visit includes returning the actiwatch and any leftover supplements, followed by a debriefing. The study measures sleep efficiency, sleep onset latency, total sleep time, and wake after sleep onset using actigraphy. It also evaluates dietary habits, gastrointestinal symptoms, anxiety levels, and depression symptoms through various questionnaires.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.65 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 39 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Healthy male or female adult between the ages of 18 and 39 years of age. * Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week) * Are a fluent English speaker * Diet which is low in magnesium * Self-identify as a poor sleeper (i.e. poor sleep quality or unrefreshing sleep). Exclusion Criteria: * Have symptoms of COVID-19 * Display evidence of current or recent sleep disorders (e.g. sleep apnea, insomnia, circadian rhythm disorders); an initial screening for sleep disorders will be conducted using the Sleep Disorders Screening Checklist - 25 (SDS-CL). Have a history of seizures or epilepsy * Have recently (within the last 12 weeks) had an infection and/or used antibiotic medication * Are pregnant, seeking to become pregnant or lactating * Are a shift worker or a recent history of shift work in the previous 6 months * Are participating in other intervention research trials * Have experienced travel across multiple time zones within the last three months or will be experiencing travel across multiple time zones during the study. * Have recently been diagnosed and/or treated for a mental health or substance use disorder. * Are currently unwell with anything that impacts sleep. * Are taking any medication which has a sedative effect * Are currently using medication which affects the central nervous system. * Are currently misusing alcohol or drugs.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Northumbria Sleep Research, Northumbria University
Newcastle, United KingdomOpen Northumbria Sleep Research, Northumbria University in Google Maps