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NCT Number: NCT07515417

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

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.

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Key information

About this study

Participants were instructed to take magnesium citrate supplements daily for 90 days and were provided with a diary to record their supplement intake and adherence throughout the study period. Any unconsumed capsules were left in the original bottle and returned during the follow-up visit to assess compliance. Participants were also asked to report any symptoms experienced during the intervention period. In addition, participants received reminders every two weeks via WhatsApp to encourage adherence to supplement intake.

Randomization codes were generated in advance using the RAND function in Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). Following confirmation of eligibility at the screening visit, participants were sequentially assigned to the next available intervention based on the pre-generated allocation list.

At baseline and after the intervention, participants completed a comprehensive assessment that included dietary intake using a Food Frequency Questionnaire (FFQ) and physical activity using the short form of the International Physical Activity Questionnaire (IPAQ). All questionnaires were administered in English. Anthropometric data, including weight and height, were self-reported by participants. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), and cognitive function was assessed using the Trail Making Test Parts A and B. Blood pressure measurements were also recorded using standardized procedures.

Blood samples were collected at baseline (prior to the intervention, during the second visit) and again after 3 months (at the final visit). Participants were instructed to fast for 8 hours before both visits, with only water permitted, to standardize conditions and minimize the influence of dietary intake on serum magnesium levels.

Approximately 10 mL of blood was drawn via venipuncture by a qualified laboratory specialist using red or yellow-top tubes. The collected samples were processed and stored at -80°C for subsequent analysis of nutritional biomarkers, including serum magnesium and HbA1c.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • History of travel to a different time zone in the previous month
  • Experiencing events that may cause severe stress for the previous 6 weeks from baseline (e.g. divorce or death or acute illness of a family member)
  • Has children between 0-2 years

Treatment and study plan

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.

Other names: Magnesium, Mg, Magnesium Citrate

Primary outcomes

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

    Time frame: 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.

    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

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

    Time frame: From enrollment to the end of treatment at 90 days

    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.

Secondary outcomes

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

    Time frame: From enrollment to the end of treatment at 90 days

    Blood pressure was measured using standardized procedures at baseline and after 90 days. Both systolic and diastolic blood pressure (mmHg) were recorded. Changes from baseline to 90 days were evaluated and compared between intervention and control groups.

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

    Time frame: From enrollment to the end of treatment at 90 days

    Blood samples were collected at baseline and after 90 days to measure serum magnesium and HbA1c levels. Serum magnesium (mmol/L) and HbA1c (%) were analyzed using standard laboratory methods. Changes from baseline to 90 days were evaluated and compared between intervention and control groups.

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

Effect of Magnesium Supplementation on Sleep Quality and Cognition in Saudi Adults: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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