CompletedNCT02235805Updated Sep 15, 2015

Magnesium and Vascular Stiffness

An interventional study of Magnesium Citrate and Placebo in Metabolic Syndrome and Obesity, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 52
Allocation: Randomized
Ages: 45 Years to 70 Years
Sex: All

Study summary

Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also beneficially affect other cardiovascular risk markers. Whether all these effects translate into improved vascular function is not known. Different vascular function markers at various stages on the pathway between diet and disease exist. One of these markers, vascular stiffness, is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To examine the integrated effects of interventions on cardiovascular risk, vascular stiffness may therefore serve as a marker at the later stage of cardiovascular disease development.

Therefore, it is imperative to examine in a 24-week, randomized, double-blind, placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time courses of an increased magnesium intake on changes in BP, other markers reflecting vascular function, and plasma biomarkers related to low-grade inflammation and vascular activity will be measured to unravel possible cause-effect relationships.

Conditions studied

Metabolic Syndrome
Obesity

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Keywords

Metabolic Syndrome
Obesity
Magnesium Supplementation
Vascular Stiffness
Vascular Function

In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.

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Lead sponsor

Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Aged between 45-70 years
Women postmenopausal: two or more years after last menstruation
BMI between 25-35 kg/m2 (overweight and slightly obese)
Plasma glucose \< 7.0 mmol/L
Serum total cholesterol \< 8.0 mmol/L
Serum triacylglycerol \< 4.5 mmol/L
No current smoker
No diabetic patients
No familial hypercholesterolemia
No abuse of drugs
Less than 21 alcoholic consumptions per week
Stable body weight (weight gain or loss \< 3 kg in the past three months)
No use of proton pump inhibitors or medication known to treat blood pressure, serum lipid or glucose metabolism
No use of dietary supplements or an investigational product within another biomedical within the previous 1-month
No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
No difficult venipuncture as evidenced during the screening visit

Exclusion criteria

Exclusion Criteria:

High habitual dietary magnesium intake
Plasma glucose ≥ 7.0 mmol/L
Serum total cholesterol ≥ 8.0 mmol/L
Serum triacylglycerol ≥ 4.5 mmol/L
Current smoker, or smoking cessation \< 12 months
Diabetic patients
Familial hypercholesterolemia
Abuse of drugs
More than 21 alcoholic consumptions per week
Unstable body weight (weight gain or loss > 3 kg in the past three months)
Use of proton pump inhibitors or medication known to treat blood pressure, serum lipid or glucose metabolism
Use of dietary supplements or an investigational product within another biomedical within the previous 1-month
Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
Not or difficult to venipuncture as evidenced during the screening visit

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 52 participants (actual)

Study arms

Experimental
Magnesium Citrate
Dietary Supplement: Magnesium Citrate
Placebo comparator
Placebo
Dietary Supplement: Placebo

Interventions

Dietary supplementMagnesium Citrate
One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks
Dietary supplementPlacebo
One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks

What researchers measure

Primary outcomes

Vascular stiffness: effects of magnesium citrate supplementation
Carotid-femoral pulse wave velocity (PWV)
Time frame: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation

Secondary outcomes

Vascular function markers: effects of magnesium citrate supplementation
Flow-mediated dilation (FMD) of the brachial artery, pulse wave analysis (PWA) (also at 12 weeks), peripheral arterial tonometry (PAT) and retinal microvascular diameters (also at 12 weeks)
Time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation
Biomarkers for low-grade inflammation and endothelial activation
Time frame: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
Blood pressure: effects of magnesium citrate supplementation
Office (also at 12 weeks) and 24-hour ambulatory blood pressure
Time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation

Other outcomes

Dietary magnesium uptake
24-hour urine samples
Time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation

Study locations

1 site

Maastricht University Medical Center
Maastricht, Netherlands

References and documents

Publications

Schutten JC, Joris PJ, Minovic I, Post A, van Beek AP, de Borst MH, Mensink RP, Bakker SJL. Long-term magnesium supplementation improves glucocorticoid metabolism: A post-hoc analysis of an intervention trial. Clin Endocrinol (Oxf). 2021 Feb;94(2):150-157. doi: 10.1111/cen.14350. Epub 2020 Oct 26. PubMed 33030273 ↗
Joris PJ, Plat J, Bakker SJ, Mensink RP. Long-term magnesium supplementation improves arterial stiffness in overweight and obese adults: results of a randomized, double-blind, placebo-controlled intervention trial. Am J Clin Nutr. 2016 May;103(5):1260-6. doi: 10.3945/ajcn.116.131466. Epub 2016 Apr 6. PubMed 27053384 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02235805
Lead sponsor: Maastricht University Medical Center
Collaborators: Top Institute Food and Nutrition
Responsible party: Sponsor
First posted: Sep 10, 2014
Start date: Sep 2014
Primary completion: Sep 2015
Completion: Sep 2015
Last update: Sep 15, 2015

Study contacts

Ronald P Mensink, PhD

principal investigator · Maastricht University Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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