Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

NCT07515417 | Completed

• 1 other identifier: HAPO-02-K-012-2025-01-2441
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults. It also assessed the effects of magnesium on selected blood markers. The main questions it aimed to answer were: Did magnesium supplementation improve sleep quality? Did magnesium supplementation improve cognitive function? Researchers compared participants who received magnesium citrate to a control group that did not receive any intervention to evaluate its effects. Participants: Took magnesium citrate (400 mg daily) for 90 days (two capsules: one in the afternoon and one 1-2 hours before bedtime) Visited Umm Al-Qura University twice (before and after the intervention) for: Sleep quality assessment Cognitive function assessment Blood sample collection to measure serum magnesium and HbA1c The control group did not receive any supplementation during the study period.

Conditions

Healthy Participants; Healthy Young Adults; Healthy Women; Healthy Adult; Healthy Adult Female Participants; Poor Sleeping Quality; Healthy; Healthy Adult Male; Healthy Adult Male Subjects; Poor Sleep Quality; Health Adult Subjects; Healthy Adult Participants; Healthy (Controls); Healthy Adult Females

Keywords

Magnesium Citrate Supplementation; Sleep Quality; Cognitive Function; Healthy Adults; Saudi Adults; Randomized Controlled Trial; Dietary Supplementation; Pittsburgh Sleep Quality Index (PSQI); Trail Making Test; Food Frequency Questionnaire (FFQ); International Physical Activity Questionnaire (IPAQ)

Outcome Measures

Primary Outcomes (2)

• Change in Sleep Quality from Baseline to 90 Days as Measured by PSQI Between Intervention and Control Groups

  The Pittsburgh Sleep Quality Index (PSQI) is a widely used and validated instrument for assessing sleep quality in both clinical and healthy populations. Both the English and Arabic versions were used in this study, and both have been previously validated. It consisted of 19 items divided into seven sleep-related components: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item was rated on a 4-point Likert scale based on frequency or severity. The component scores were summed to yield a global PSQI score ranging from 0 to 21. A score greater than five indicated poor sleep quality, while a score of five or less indicated good sleep quality. Participants were considered to have improved sleep quality if their PSQI scores decreased over time, particularly if their scores reached five or below

  Participants were considered to have improved sleep quality if PSQI scores decreased from baseline to 90 days, especially if ≤5. Sleep outcomes were also compared between intervention and control groups after 90 days.

• Change in Cognitive Function from Baseline to 90 Days as Measured by Trail Making Test (Parts A and B) Between Intervention and Control Group

  Cognitive function was assessed using the Trail Making Test (Parts A and B). The test measured processing speed, attention, and executive function. The primary outcome was the time (in seconds) required to complete each part, with longer times indicating poorer cognitive performance. Changes in completion time from baseline to 90 days were evaluated and compared between intervention and control groups.

  From enrollment to the end of treatment at 90 days

Secondary Outcomes (2)

• Change in Blood Pressure from Baseline to 90 Days Between Intervention and Control Groups

  From enrollment to the end of treatment at 90 days

• Change in Serum Magnesium and HbA1C Levels from Baseline to 90 Days Between Intervention and Control Groups

  From enrollment to the end of treatment at 90 days

Study Arms (2)

Control

NO INTERVENTION

Eligible participants in the control group, identified as having poor sleep quality, did not receive any intervention during the study period. All outcome measures, including sleep quality, cognitive function, anthropometric data, questionnaires, and blood samples, were collected at baseline and again after the 90-day study period.

Magnesium Citrate

EXPERIMENTAL

Eligible participants received magnesium citrate (400 mg elemental magnesium/day) for 90 days, administered as two divided doses (afternoon and 1-2 hours before bedtime). Compliance was monitored through participant diaries and returned capsule counts.

Dietary Supplement: Magnesium 400Mg

Interventions

Magnesium 400Mg DIETARY_SUPPLEMENT

Magnesium supplementation was administered to eligible participants using magnesium citrate tablets (Solgar®, USA), a highly bioavailable form commonly used in research. The supplements were purchased from Al Nahdi Pharmacy (Saudi Arabia) and selected based on previous studies demonstrating good absorption and effectiveness. Participants received a total daily dose of 400 mg elemental magnesium. Eligible participants were instructed to take the supplement for 90 days, divided into two doses: one in the afternoon and one 1-2 hours before bedtime. The supplement was provided in bottles containing 120 tablets. Participants were asked to maintain their usual diet and lifestyle. Compliance was monitored using participant diaries and by counting remaining capsules returned at the follow-up visit.

Also known as: Magnesium, Mg, Magnesium Citrate

Magnesium Citrate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 years and above
• Poor Sleep Quality (\>5 PSQI score)
• Living in Saudi Arabia

You may not qualify if:

• Children less than 18 years old
• Good Sleep Quality (5 or less PSQI score)
• Pregnant or breastfeeding
• Current smoker
• History of sleep disorder
• History of cognitive impairment
• Diagnosed with a disease (e.g. diabetes, hypertension, celiac, psychiatric disease)
• Acute phase of diseases (e.g. cardiovascular)
• History of head injury (e.g. accident) or neurological disorders (e.g. seizures)/neurodevelopment disorders
• Use of prescribed medications within the past 3 months that may influence sleep
• Current use of hormone therapy (e.g. thyroxine, insulin, growth hormone, contraceptives)
• Use of dietary supplements within the previous 3 months (e.g. vitamin D, omega-3..etc)
• Food allergies/intolerances (e.g. eggs, nuts, milk)
• Excessive caffeine consumption (\>450 mg/day, more than 4 cups)
• Shift worker or work schedules that cause irregular sleep patterns

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Mecca, Saudi Arabia

Location

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Magnesium; magnesium citrate

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: October 1, 2024
• Primary Completion: January 25, 2026
• Study Completion: June 30, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)