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

Umm Al-Qura University

Status: Active, not recruiting

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

Treatments: Dietary Supplement: Magnesium 400Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07515417

HAPO-02-K-012-2025-01-2441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Dietary Supplement: Magnesium 400Mg