Improving Sleep Health Through Magnesium Supplementation

NCT07359612 | Active Not Recruiting

• 1 other identifier: 54246
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Health

Keywords

nutrition, sleep, magnesium

Outcome Measures

Primary Outcomes (12)

• Actigraphy - Sleep onset latency

  recorded minutes taken from intention to sleep to sleep initiation

  Change from baseline following 56 days of supplement consumption

• Sleep Diary -Sleep Latency

  how long, in minutes, the individual felt it took them to fall asleep after intending to sleep

  Change from baseline following 56 days of supplement consumption

• Actigraphy - total sleep time

  recorded minutes asleep over entire sleep period

  Change from baseline following 56 days of supplement consumption

• Sleep Diary - total sleep time

  how long, in minutes, the individual reports being asleep during the night between initiation and termination of sleep, accounting for nocturnal wake periods

  Change from baseline following 56 days of supplement consumption

• Actigraphy - Wake after sleep onset (WASO)

  recorded minutes awake during the entire sleep period following sleep onset

  Change from baseline following 56 days of supplement consumption

• Sleep Diary - Wake After Sleep Onset (WASO)

  how long, in minutes, the individual reports being awake during the night after sleep initiation

  Change from baseline following 56 days of supplement consumption

• Actigraphy - Sleep efficiency

  ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)

  Change from baseline following 56 days of supplement consumption

• Sleep Diary - Sleep efficiency

  Total Sleep Time divided by Time in Bed x 100, expressed as a percentage

  Change from baseline following 56 days of supplement consumption

• Dietary assessment- 7 day dietary recall

  Participants will complete 7 day dietary recall questionnaire

  Change from baseline following 56 days of supplement consumption

• Gastrointestinal symptoms questionnaire

  When completing the assessment, participants will answer in relation to their experiences in the previous 7 days. 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

  Change from baseline following 56 days of supplement consumption

• Generalized Anxiety Disorder 7- Item Scale scores (GAD-7)

  The GAD-7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. It contains 7 items with answers ranging from "Not at all" to "Nearly every day".

  Change from baseline following 56 days of supplement consumption

• Patient Health Questionnaire (PHQ9)

  The PHQ9 will screen for depression symptoms. It is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: It incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.

  Change from baseline following 56 days of supplement consumption

Secondary Outcomes (1)

• Munich Chronotype Questionnaire (MCTQ)

  Change from baseline following 56 days of supplement consumption

Study Arms (1)

Magnesium 250 mg

EXPERIMENTAL

Participants will consume 250mg of magnesium supplement daily over a 56-day period.

Dietary Supplement: Magnesium 250 mg

Interventions

Magnesium 250 mg DIETARY_SUPPLEMENT

Participants will consume 250 mg of magnesium once a day preferably with a meal

Magnesium 250 mg

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead
• Unilever R&D: collaborator

Study Sites (1)

Northumbria Sleep Research, Northumbria University

Newcastle, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Magnesium

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 15, 2023
• Primary Completion: July 31, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)