Sleep QualityNCT07894562

Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults

A study testing Magnesium bisglycinate and magnesium malate in people with Sleep Quality and Magnesium Deficiency, run by José Enrique de la Rubia Ortí, Ph at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Quality, Magnesium Deficiency, Sleep Initiation and Maintenance Disorders
What is being tested?: Magnesium bisglycinate and magnesium malate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteSpain
Study dates: 19 Oct 2026to 31 Mar 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men or women aged 18 to 65 years.
Subjective sleep disturbance, defined as a Pittsburgh Sleep Quality Index (PSQI) score > 5 or an Insomnia Severity Index (ISI) score > 8.
No diagnosed chronic disease that could significantly affect the study variables.
Not participating simultaneously in another clinical trial.
Signed informed consent after receiving full information about the study.
Sufficient reading comprehension to complete the questionnaires in Spanish.

Who cannot join

Pregnancy, breastfeeding or planning a pregnancy during the study.
Chronic kidney failure or severe impairment of renal function.
Severe, non-stabilized psychiatric disorders or active treatment with psychotropic drugs.
Use of magnesium supplements or other supplements that may interfere with the study variables within the 4 weeks before the start of the study.
Known allergy to any component of MAGNESIO TOTAL.
Sleep disorders requiring specific pharmacological treatment.
Rotating shift work.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad Católica de Valencia San Vicente Mártir
Valencia, Valencia, 46001

Other trials in Spain

About this study

Official title: Efficacy of MAGNESIO TOTAL in Improving Sleep and Health-Related Quality of Life in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Read the detailed description

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.

Conditions: Sleep Quality, Magnesium Deficiency, Sleep Initiation and Maintenance Disorders, Quality of Life
Being tested: Magnesium bisglycinate and magnesium malate, Placebo
Keywords: Magnesium, Magnesium Bisglycinate, Magnesium Malate, Dietary Supplement, Pittsburgh Sleep Quality Index, Inflammation, Oxidative Stress
Medical subject headings: Sleep Initiation and Maintenance Disorders, Magnesium Deficiency, Inflammation

What participants receive

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

Magnesium bisglycinate and magnesium malateDietary supplement
Also called MAGNESIO TOTAL
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.
PlaceboOther
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.

Study groups in NCT07894562
Study group	Role	What they receive
MAGNESIO TOTAL	Experimental	Participants receive MAGNESIO TOTAL (magnesium bisglycinate and magnesium malate), 2 capsules per day providing 215 mg of elemental magnesium, for 8 weeks. Receives: Dietary Supplement: Magnesium bisglycinate and magnesium malate
Placebo	Placebo comparator	Participants receive placebo capsules identical in appearance, taste and format to MAGNESIO TOTAL, 2 capsules per day, for 8 weeks. Receives: Other: Placebo

What is being measured

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

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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (week 0) and week 8

Secondary outcomes (19)

Change in total sleep duration
Self-reported total hours of actual sleep per night during the past month, obtained from the PSQI (hours).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (week 0), week 4 and week 8
Change in total antioxidant capacity
Total antioxidant capacity of plasma/serum, where technically feasible.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: From baseline (week 0) to week 8

Timeline

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

19 Oct 202631 Mar 2027

First posted26 Oct 2026
Study start19 Oct 2026
Primary completion16 Dec 2026 (estimated)
Study completion31 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep QualityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: Prospective, longitudinal, randomized (1:1), double-blind, placebo-controlled trial with two parallel groups: MAGNESIO TOTAL or identical placebo for 8 weeks, with assessments at baseline (week 0), week 4 and week 8.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07894562
Sponsor's protocol ID: UCV/2025-2026/129
Status last verified: Oct 2026
First submitted: 17 Oct 2026
Last updated: 2 Nov 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 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Quality trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of MAGNESIO TOTAL in Improving Sleep and Health-Related Quality of Life in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT07894562
Acronym / sponsor ID: UCV/2025-2026/129
Conditions: Sleep Quality, Magnesium Deficiency, Sleep Initiation and Maintenance Disorders, Quality of Life
Keywords: Magnesium, Magnesium Bisglycinate, Magnesium Malate, Dietary Supplement, Pittsburgh Sleep Quality Index, Inflammation, Oxidative Stress
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 50 participants (actual)
Lead sponsor: José Enrique de la Rubia Ortí, PhUniversity, hospital or other
Collaborators: IVB Wellness Lab
Study start: 19 Oct 2026 (actual)
Primary completion: 16 Dec 2026 (estimated)
Study completion: 31 Mar 2027 (estimated)
First posted: 26 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants: adults aged 18 to 65 years with subjective sleep disturbance (Pittsburgh Sleep Quality Index [PSQI] > 5 or Insomnia Severity Index [ISI] > 8).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Prospective, longitudinal, randomized (1:1), double-blind, placebo-controlled trial with two parallel groups: MAGNESIO TOTAL or identical placebo for 8 weeks, with assessments at baseline (week 0), week 4 and week 8.

Arm	Type	Receives
MAGNESIO TOTAL	Experimental	Dietary Supplement: Magnesium bisglycinate and magnesium malateParticipants receive MAGNESIO TOTAL (magnesium bisglycinate and magnesium malate), 2 capsules per day providing 215 mg of elemental magnesium, for 8 weeks.
Placebo	Placebo comparator	Other: PlaceboParticipants receive placebo capsules identical in appearance, taste and format to MAGNESIO TOTAL, 2 capsules per day, for 8 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men or women aged 18 to 65 years.
Subjective sleep disturbance, defined as a Pittsburgh Sleep Quality Index (PSQI) score > 5 or an Insomnia Severity Index (ISI) score > 8.
No diagnosed chronic disease that could significantly affect the study variables.
Not participating simultaneously in another clinical trial.
Signed informed consent after receiving full information about the study.

Key exclusion criteria (7 listed)

Pregnancy, breastfeeding or planning a pregnancy during the study.
Chronic kidney failure or severe impairment of renal function.
Severe, non-stabilized psychiatric disorders or active treatment with psychotropic drugs.
Use of magnesium supplements or other supplements that may interfere with the study variables within the 4 weeks before the start of the study.
Known allergy to any component of MAGNESIO TOTAL.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnesium bisglycinate and magnesium malateAlso: MAGNESIO TOTALMAGNESIO 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.	Dietary supplement	MAGNESIO TOTAL
PlaceboPlacebo 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.	Other	Placebo

Primary outcome

Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (week 0) and week 8
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.
Change in insomnia severity measured by the Insomnia Severity Index (ISI)
Time frame: Baseline (week 0) and week 8
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).
Change in health-related quality of life measured by the EQ-5D-5L index
Time frame: Baseline (week 0) and week 8
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.
Change in self-rated health measured by the EQ visual analogue scale (EQ VAS)
Time frame: Baseline (week 0) and week 8
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.

19 secondary outcomes

Change in total sleep duration
Time frame: Baseline (week 0) and week 8
Change in sleep onset latency
Time frame: Baseline (week 0) and week 8
Change in habitual sleep efficiency
Time frame: Baseline (week 0) and week 8
Change in body mass index (BMI)
Time frame: Baseline (week 0) and week 8
Change in waist circumference
Time frame: Baseline (week 0) and week 8
Change in systolic blood pressure
Time frame: Baseline (week 0) and week 8
Change in diastolic blood pressure
Time frame: Baseline (week 0) and week 8
Change in fasting plasma glucose
Time frame: Baseline (week 0), week 4 and week 8
Change in fasting insulin
Time frame: Baseline (week 0), week 4 and week 8
Change in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline (week 0), week 4 and week 8
Change in serum interleukin-6 (IL-6)
Time frame: Baseline (week 0), week 4 and week 8
Change in serum tumor necrosis factor alpha (TNF-α)
Time frame: Baseline (week 0), week 4 and week 8
Change in evening serum cortisol
Time frame: Baseline (week 0), week 4 and week 8
Change in lipid peroxidation measured by malondialdehyde (MDA)
Time frame: Baseline (week 0), week 4 and week 8
Change in total antioxidant capacity
Time frame: Baseline (week 0), week 4 and week 8
Change in body weight
Time frame: Baseline (week 0) and week 8
Change in time in bed
Time frame: Baseline (week 0) and week 8
Adherence to the study product
Time frame: Week 4 and week 8
Number of participants with adverse events
Time frame: From baseline (week 0) to week 8

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

José Enrique de la Rubia Ortí, PhD principal investigator

Universidad Católica de Valencia San Vicente Mártir

Gonzalo Mariscal Ruiz-Rico principal investigator

Universidad Católica de Valencia San Vicente Mártir

Ana Belén Carriquí Suárez study director

Universidad Católica de Valencia San Vicente Mártir

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium bisglycinate and magnesium malate in people with Sleep Quality and Magnesium Deficiency, run by José Enrique de la Rubia Ortí, Ph at 1 site in Spain.

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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 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 Spain. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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 measured by the Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline (week 0) and week 8). The study lists 4 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 NCT07894562.

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 2 Nov 2026.