How taking magnesium affects sleep and health in adults with poor sleep quality: a study with randomized blinding and placebo control

Not Applicable

Completed

• Conditions: Adults with nonclinical insomnia symptoms; Mental and Behavioural Disorders

• Registration Number: ISRCTN70584524
• Lead Sponsor: pgraded Formulas, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-07-07
• Study Start: 2023-11-09
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Adults between the ages of 25 to 55 with nonclinical insomnia symptoms

Exclusion Criteria

1. Severe insomnia (based on the Insomnia Severity Index (ISI = 22) or absence of insomnia (ISI < 8);
2. History of a disorder affecting sleep quality
3. Events that could cause severe stress within 2 weeks of baseline
4. Use of medication that could influence sleep patterns, within 1 month of baseline
5. Current use of hormone therapy
6. Binge drinking
7. Smoking
8. High caffeine intake
9. Work schedule that causes irregular sleep patterns
10. History of travel to a different time zone within 1 month of study
11. Low or high body mass index (BMI = 18 kg/m² or =30 kg/m²)
12. Pregnant, trying to conceive, or breastfeeding
13. Taking sleep supplements or medication
14. Unwilling to abstain from other magnesium product use for two weeks leading up to trial initiation and during the trial
15. Individuals deemed incompatible with the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Sleep measured by:<br> 1. Questionnaires:<br> 1.1. Insomnia Severity Index was measured at baseline and post each condition<br> 1.2. Pittsburgh Sleep Quality Index (PSQI) was measured at baseline and post each condition<br> 1.3. Berlin Questionnaire was measured at baseline and post each condition<br> 1.4. Restorative Sleep Questionnaire was measured at baseline and post each condition<br> 2. Objective wearable measure:<br> Oura Ring which is a multisensory wearable device that quantifies night-time and daytime activity was measured daily<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Profile of Mood States was measured at baseline and post each condition<br> 2. Flinders Fatigue Scale was measured at baseline and post each condition<br> 3. Perceived Stress Scale was measured at baseline and post each condition<br> 4. Pain and Sleep Questionnaire Three-item Index was measured at baseline and post each condition<br> 5. Trait Anxiety Inventory. was measured at baseline and post each condition<br> 6. Adherence and adverse events: was measured daily via a questionnaire<br>