Efficacy of MAGNESIO TOTAL in Improving Sleep and Health-Related Quality of Life in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor study identifier
interventional
55
1 country
1
Study Start
October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2026
Actual (reported)October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 26, 2026
Actual (reported)December 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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).
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.
Participants receive MAGNESIO TOTAL (magnesium bisglycinate and magnesium malate), 2 capsules per day providing 215 mg of elemental magnesium, for 8 weeks.
Participants receive placebo capsules identical in appearance, taste and format to MAGNESIO TOTAL, 2 capsules per day, for 8 weeks.
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.
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.
Universidad Católica de Valencia San Vicente Mártir
Valencia, Valencia, 46001, Spain
José Enrique de la Rubia Ortí, PhD
Universidad Católica de Valencia San Vicente Mártir
Gonzalo Mariscal Ruiz-Rico
Universidad Católica de Valencia San Vicente Mártir
Ana Belén Carriquí Suárez
Universidad Católica de Valencia San Vicente Mártir
Ruth Gabriela Cárdenas Salazar
Universidad Católica de Valencia San Vicente Mártir
First Submitted
October 17, 2026
First Posted
October 26, 2026
Study Start
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.
Baseline (week 0) and week 8
Change in total sleep duration
Baseline (week 0) and week 8
Change in sleep onset latency
Baseline (week 0) and week 8
Change in habitual sleep efficiency
Baseline (week 0) and week 8
Change in body mass index (BMI)
Baseline (week 0) and week 8
Change in waist circumference
Baseline (week 0) and week 8
Correlation between changes in biological markers and changes in sleep and quality of life
Baseline (week 0) to week 8
Contact the study team to confirm eligibility.
October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
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.
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Source: ClinicalTrials.gov.
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