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HealthyNCT07515417

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

A study testing Magnesium 400Mg in people with Healthy and Health Adult Subjects, run by Umm Al-Qura University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Magnesium 400Mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteSaudi Arabia
Study dates
1 Oct 2024to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Umm Al-Qura University

    Mecca

Other trials in Saudi Arabia

About this study

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

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:

Read more

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.

Read the detailed description

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.

Being tested
Magnesium 400Mg
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)
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium 400MgDietary supplement

    Also called Magnesium, Mg, Magnesium Citrate

    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.

Study groups in NCT07515417
Study groupRoleWhat they receive
ControlNo interventionEligible 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 CitrateExperimentalEligible 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.
Receives: Dietary Supplement: Magnesium 400Mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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.

  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

    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.

    Measured: From enrollment to the end of treatment at 90 days

Secondary outcomes (2)

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

    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.

    Measured: From enrollment to the end of treatment at 90 days

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

    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.

    Measured: From enrollment to the end of treatment at 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start1 Oct 2024
  3. Primary completion25 Jan 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07515417
Sponsor's protocol ID
HAPO-02-K-012-2025-01-2441
Status last verified
Jul 2026
First submitted
31 Mar 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations, as the dataset contains sensitive information that could potentially identify participants. Data will be presented in aggregate form to ensure participant anonymity.

Publications

  • Khan MA, Al-Jahdali H. The consequences of sleep deprivation on cognitive performance. Neurosciences (Riyadh). 2023 Apr;28(2):91-99. doi: 10.17712/nsj.2023.2.20220108.

    PubMed 37045455

  • Baattaiah BA, Alharbi MD, Babteen NM, Al-Maqbool HM, Babgi FA, Albatati AA. The relationship between fatigue, sleep quality, resilience, and the risk of postpartum depression: an emphasis on maternal mental health. BMC Psychol. 2023 Jan 13;11(1):10. doi: 10.1186/s40359-023-01043-3.

    PubMed 36635743

  • Zhang Y, Chen C, Lu L, Knutson KL, Carnethon MR, Fly AD, Luo J, Haas DM, Shikany JM, Kahe K. Association of magnesium intake with sleep duration and sleep quality: findings from the CARDIA study. Sleep. 2022 Apr 11;45(4):zsab276. doi: 10.1093/sleep/zsab276.

    PubMed 34883514

  • Shamim SA, Warriach ZI, Tariq MA, Rana KF, Malik BH. Insomnia: Risk Factor for Neurodegenerative Diseases. Cureus. 2019 Oct 26;11(10):e6004. doi: 10.7759/cureus.6004.

    PubMed 31807391

  • Bamagoos AA, Altayeb AA, Rawas HF, Alsulaimani SS, Basurrah MA, Aleissi SA, Wali SO. Patterns of Sleep and Napping in Saudi Arabia: A Cross-sectional Evaluation. Saudi J Med Med Sci. 2025 Apr-Jun;13(2):124-132. doi: 10.4103/sjmms.sjmms_679_24. Epub 2025 Apr 21.

    PubMed 40352339

  • Barbagallo M, Veronese N, Dominguez LJ. Magnesium in Aging, Health and Diseases. Nutrients. 2021 Jan 30;13(2):463. doi: 10.3390/nu13020463.

    PubMed 33573164

  • Gallagher C, Austin V, Dunlop KA, Dally J, Taylor K, Pullinger SA, Edwards BJ. Effects of Supplementing Zinc Magnesium Aspartate on Sleep Quality and Submaximal Weightlifting Performance, following Two Consecutive Nights of Partial Sleep Deprivation. Nutrients. 2024 Jan 13;16(2):251. doi: 10.3390/nu16020251.

    PubMed 38257144

  • Ahmed AE, Al-Jahdali F, AlALwan A, Abuabat F, Bin Salih SA, Al-Harbi A, Baharoon S, Khan M, Ali YZ, Al-Jahdali H. Prevalence of sleep duration among Saudi adults. Saudi Med J. 2017 Mar;38(3):276-283. doi: 10.15537/smj.2017.3.17101.

    PubMed 28251223

  • Ajabnoor SM, Jambi H, Bahijri S. Development and validation of a food frequency questionnaire in adult Saudi subjects in Jeddah city. BMC Public Health. 2024 Jan 2;24(1):9. doi: 10.1186/s12889-023-17511-9.

    PubMed 38166899

  • Gholizadeh-Moghaddam M, Ghasemi-Tehrani H, Askari G, Jaripur M, Clark CCT, Rouhani MH. Effect of magnesium supplementation in improving hyperandrogenism, hirsutism, and sleep quality in women with polycystic ovary syndrome: A randomized, placebo-controlled clinical trial. Health Sci Rep. 2022 Dec 29;6(1):e1013. doi: 10.1002/hsr2.1013. eCollection 2023 Jan.

    PubMed 36620514

  • Macian N, Duale C, Voute M, Leray V, Courrent M, Bode P, Giron F, Sonneville S, Bernard L, Joanny F, Menard K, Ducheix G, Pereira B, Pickering G. Short-Term Magnesium Therapy Alleviates Moderate Stress in Patients with Fibromyalgia: A Randomized Double-Blind Clinical Trial. Nutrients. 2022 May 17;14(10):2088. doi: 10.3390/nu14102088.

    PubMed 35631229

  • Grandner MA, Jackson NJ, Izci-Balserak B, Gallagher RA, Murray-Bachmann R, Williams NJ, Patel NP, Jean-Louis G. Social and Behavioral Determinants of Perceived Insufficient Sleep. Front Neurol. 2015 Jun 5;6:112. doi: 10.3389/fneur.2015.00112. eCollection 2015.

    PubMed 26097464

  • Alqarni RA, Almutairi NS, Albalawi AS, Alsulami MB, Alhashrani MA, Bin Abdulrahman KA. Test-retest reliability of the Arabic version of the Pittsburgh Sleep Quality Index. Medicine (Baltimore). 2025 Jan 17;104(3):e41269. doi: 10.1097/MD.0000000000041269.

    PubMed 39833037

  • Metwally A, Alalawi AD, Al Sarrar AA, Alamin OM, Saad AA, Almalki MD. Prevalence of Insomnia and Its Associated Factors in the General Population of Saudi Arabia: A Cross-Sectional Study. Cureus. 2023 Aug 29;15(8):e44342. doi: 10.7759/cureus.44342. eCollection 2023 Aug.

    PubMed 37779810

  • Watanabe M, Maemura K, Kanbara K, Tamayama T, Hayasaki H. GABA and GABA receptors in the central nervous system and other organs. Int Rev Cytol. 2002;213:1-47. doi: 10.1016/s0074-7696(02)13011-7.

    PubMed 11837891

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium 400Mg in people with Healthy and Health Adult Subjects, run by Umm Al-Qura University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07515417, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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Clinical Trial NCT07515417 | AzTrials