An interventional study of Magnesium bisglycinate and magnesium malate and Placebo in Sleep Quality, Magnesium Deficiency and Sleep Initiation and Maintenance Disorders, sponsored by José Enrique de la Rubia Ortí, Ph. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by José Enrique de la Rubia Ortí, Ph · Not applicable, Interventional, and Treatment
This randomized, double-blind, placebo-controlled trial evaluates whether MAGNESIO TOTAL, a dietary supplement containing magnesium bisglycinate and magnesium malate (215 mg elemental magnesium per day), improves sleep quality and health-related quality of life in adults aged 18 to 65 years with subjective sleep complaints. Participants will take the supplement or an identical placebo for 8 weeks. The study will also explore changes in metabolic, inflammatory and oxidative stress markers.
Magnesium is a cofactor in more than 600 enzymatic reactions and participates in mechanisms relevant to sleep regulation, including NMDA receptor antagonism, modulation of the hypothalamic-pituitary-adrenal axis and enhancement of GABAergic activity. Subclinical magnesium deficiency is common, and previous trials suggest that magnesium supplementation may improve sleep quality and insomnia severity. However, evidence in young and middle-aged adults with subclinical sleep complaints is limited, and few studies have simultaneously assessed sleep, quality of life, metabolic, inflammatory and oxidative stress outcomes.
Design: prospective, longitudinal, randomized (1:1), double-blind, placebo-controlled clinical trial with two parallel groups, conducted at the Universidad Católica de Valencia San Vicente Mártir (Valencia, Spain).
Participants: adults aged 18 to 65 years with subjective sleep disturbance (Pittsburgh Sleep Quality Index [PSQI] > 5 or Insomnia Severity Index [ISI] > 8).
Intervention: MAGNESIO TOTAL (IVB Wellness Lab), containing Albion® magnesium bisglycinate and magnesium malate, 2 capsules per day (215 mg elemental magnesium) for 8 weeks. The control group will receive an identical-appearing placebo (inert excipient such as microcrystalline cellulose or starch) following the same regimen. Randomization will use a computer-generated sequence with allocation concealment.
Visits: baseline (week 0), intermediate (week 4 ± 3 days) and final (week 8 ± 3 days). At baseline and week 8, participants will complete the PSQI, ISI and EQ-5D-5L, and anthropometric measurements and blood pressure will be obtained. Fasting blood samples (metabolic, inflammatory and oxidative stress markers) and evening blood samples for serum cortisol will be collected at baseline, week 4 and week 8. At week 4, adherence (capsule count; adequate adherence ≥ 80%), tolerability and adverse events will also be assessed.
Statistical analysis: within-group changes will be analyzed with paired t-tests or Wilcoxon tests and between-group differences with independent t-tests or Mann-Whitney U tests, with 95% confidence intervals. Correlations between biological changes and changes in sleep and quality of life will be explored (Pearson or Spearman), and multiple linear regression models will adjust for age, sex, baseline BMI and lifestyle habits. Multiple comparisons will be corrected using Bonferroni or Benjamini-Hochberg methods.
The study has been approved by the Research Ethics Committee of the Universidad Católica de Valencia San Vicente Mártir (code UCV/2025-2026/129) and complies with the Declaration of Helsinki, Spanish Organic Law 3/2018 and the EU General Data Protection Regulation.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's planned enrollment of 55 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →José Enrique de la Rubia Ortí, Ph is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants receive MAGNESIO TOTAL (magnesium bisglycinate and magnesium malate), 2 capsules per day providing 215 mg of elemental magnesium, for 8 weeks.
Dietary Supplement: Magnesium bisglycinate and magnesium malate
Participants receive placebo capsules identical in appearance, taste and format to MAGNESIO TOTAL, 2 capsules per day, for 8 weeks.
Other: Placebo
MAGNESIO TOTAL (IVB Wellness Lab) is a food supplement containing Albion® magnesium bisglycinate and magnesium malate. Two capsules per day provide 215 mg of elemental magnesium. Administered orally for 8 weeks following the manufacturer's recommended regimen.
Also known as: MAGNESIO TOTAL
Placebo capsules identical in appearance, taste and format to MAGNESIO TOTAL, containing an inert excipient (e.g., microcrystalline cellulose or starch) and no magnesium. Two capsules per day for 8 weeks.
Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Global PSQI score (sum of 7 components, each 0-3). Range 0-21; higher scores indicate worse sleep quality. Change from baseline to week 8 compared between groups.
Time frame: Baseline (week 0) and week 8
Change in insomnia severity measured by the Insomnia Severity Index (ISI)
ISI total score (7 items, each 0-4). Range 0-28; higher scores indicate greater insomnia severity (0-7 no clinically significant insomnia, 8-14 subthreshold, 15-21 moderate, 22-28 severe).
Time frame: Baseline (week 0) and week 8
Change in health-related quality of life measured by the EQ-5D-5L index
EQ-5D-5L descriptive system (mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each rated on 5 levels), converted into a utility index using the Spanish value set. Index values up to 1 (full health); higher values indicate better health-related quality of life.
Time frame: Baseline (week 0) and week 8
Change in self-rated health measured by the EQ visual analogue scale (EQ VAS)
EQ VAS from the EQ-5D-5L questionnaire. Range 0 (worst imaginable health) to 100 (best imaginable health); higher scores indicate better self-rated health.
Time frame: Baseline (week 0) and week 8
Change in total sleep duration
Self-reported total hours of actual sleep per night during the past month, obtained from the PSQI (hours).
Time frame: Baseline (week 0) and week 8
Change in sleep onset latency
Self-reported time (minutes) needed to fall asleep each night during the past month, obtained from the PSQI.
Time frame: Baseline (week 0) and week 8
Change in habitual sleep efficiency
Sleep efficiency (%) calculated as hours slept divided by hours spent in bed x 100, obtained from the PSQI. Higher values indicate better sleep efficiency.
Time frame: Baseline (week 0) and week 8
Change in body mass index (BMI)
BMI (kg/m\^2) calculated from body weight (kg), measured fasting with light clothing on a calibrated scale, and height (cm), measured with a fixed stadiometer.
Time frame: Baseline (week 0) and week 8
Change in waist circumference
Waist circumference (cm) measured at the midpoint between the lower rib margin and the iliac crest, standing, at the end of a normal expiration, with an inextensible tape.
Time frame: Baseline (week 0) and week 8
Change in systolic blood pressure
Systolic blood pressure (mmHg) measured seated after at least 5 minutes of rest with a validated device; three readings 1 minute apart, using the mean of the last two.
Time frame: Baseline (week 0) and week 8
Change in diastolic blood pressure
Diastolic blood pressure (mmHg) measured seated after at least 5 minutes of rest with a validated device; three readings 1 minute apart, using the mean of the last two.
Time frame: Baseline (week 0) and week 8
Change in fasting plasma glucose
Fasting glucose (mg/dL) determined by enzymatic spectrophotometric methods in venous blood obtained after at least 8 hours of fasting.
Time frame: Baseline (week 0), week 4 and week 8
Change in fasting insulin
Fasting serum insulin (μIU/mL) in venous blood obtained after at least 8 hours of fasting.
Time frame: Baseline (week 0), week 4 and week 8
Change in high-sensitivity C-reactive protein (hs-CRP)
Serum hs-CRP (mg/L) quantified by high-sensitivity immunoassay (turbidimetry or chemiluminescence) in fasting venous blood.
Time frame: Baseline (week 0), week 4 and week 8
Change in serum interleukin-6 (IL-6)
Serum IL-6 (pg/mL) quantified by ELISA or multiplex immunoassay in fasting venous blood.
Time frame: Baseline (week 0), week 4 and week 8
Change in serum tumor necrosis factor alpha (TNF-α)
Serum TNF-α (pg/mL) quantified by ELISA or multiplex immunoassay in fasting venous blood.
Time frame: Baseline (week 0), week 4 and week 8
Change in evening serum cortisol
Serum cortisol (μg/dL) in blood drawn in the evening (16:00-18:00 h), determined by chemiluminescence immunoassay or LC-MS/MS.
Time frame: Baseline (week 0), week 4 and week 8
Change in lipid peroxidation measured by malondialdehyde (MDA)
Plasma/serum malondialdehyde concentration as a marker of oxidative lipid damage, where technically feasible.
Time frame: Baseline (week 0), week 4 and week 8
Change in total antioxidant capacity
Total antioxidant capacity of plasma/serum, where technically feasible.
Time frame: Baseline (week 0), week 4 and week 8
Change in body weight
Body weight (kg) measured fasting, barefoot and in light clothing on a calibrated scale (precision 100 g).
Time frame: Baseline (week 0) and week 8
Change in time in bed
Self-reported hours spent in bed per night during the past month, calculated from usual bedtime and wake-up time reported in the PSQI (hours).
Time frame: Baseline (week 0) and week 8
Adherence to the study product
Percentage of prescribed capsules consumed, calculated by counting dispensed and returned capsules and supported by the participant's daily intake log. Adequate adherence is defined as ≥ 80% of prescribed doses.
Time frame: Week 4 and week 8
Number of participants with adverse events
Adverse events reported by participants or detected by investigators, recorded with severity (mild, moderate, severe) and relationship to the study product (related, not related, uncertain).
Time frame: From baseline (week 0) to week 8
Correlation between changes in biological markers and changes in sleep and quality of life
Pearson or Spearman correlation coefficients between changes in metabolic, inflammatory, cortisol and oxidative stress markers and changes in PSQI, ISI and EQ-5D-5L scores. Multiple linear regression models will identify predictors of change, adjusting for age, sex, baseline BMI and lifestyle habits.
Time frame: Baseline (week 0) to week 8
Plan to share: No — Individual participant data (IPD) will not be shared due to institutional data protection policies and the sensitive health-related nature of the data. Data will be handled in compliance with the EU General Data Protection Regulation (GDPR) and Spanish Organic Law 3/2018, and will remain confidential and accessible only to the research team.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sleep Initiation and Maintenance Disorders →
José Enrique de la Rubia Ortí, Ph